“Ensuring Infants & Children with Bronchiolitis Receive the Best Possible Care” Evidence-Based Practice Guideline for the Management of Bronchiolitis in Infants and Children 2 October 2006 Funded by Southern Health Clinical Practice Guideline for the Management of Bronchiolitis in Infants and Children ‘Health for Kids in the South East’ is a Southern Health initiative funded by the Victorian Department of Human Services through the Hospital Admission Risk Program (HARP). This project aims to improve health outcomes for children and young people in the Southern Health catchment area by supporting evidence-based best practice and facilitating partnerships within and between acute and community health services Electronic copies of this report can be obtained from the Health for Kids in the South East Internet site at: http://www.mihsr.monash.org/hfk/pdf/hfkbronchguideline.pdf For further information, please contact: Dr Claire Harris Project Manager, Health for Kids in the South East Centre for Clinical Effectiveness Monash Institute of Health Services Research Monash Medical Centre Clayton 3168 Australia Phone: +61 3 9594 7576 Email: claire.harris@med.monash.edu.au Acknowledgement Southern Health supported the guideline development process, individual departments facilitated staff participation, and many staff members contributed in their own time. We thank the following people for their important contribution to the development of this guideline. Name Dr Trevor Kerr Role Unit Head, Southern Health, Microbiology Contribution Expert knowledge on RSV testing Senior Scientists, Virus Identification Unit Victorian Infectious Disease Reference Laboratory Expert knowledge on RSV testing Laboratory Staff Southern Cross Pathology, Australia Expert knowledge on RSV testing Judy Brett Nurse Consultant, Southern Health Infection Control and Epidemiology Unit Advice on infection control measures Emily England John Wheeler Metropolitan Ambulance Service (MAS) Consultation in regard to MAS protocols Funding for the development of this guideline was provided by the Victorian Department of Human Services Hospital Admission Risk Project. The Health for Kids Paediatric Evidence Centre was supported by a grant from the Windermere Foundation Ltd. Disclaimer This guideline is designed to assist clinicians by providing a framework of expected care based on the best available evidence at the time of publication. It should not replace clinical judgment in patient care. Southern Health Clinical Practice Guideline for the Management of Bronchiolitis in Infants and Children Contents Summary of Recommendations 1. Introduction 1.1 Statement of intent 2. Natural History and Diagnosis 2.1 2.2 2.3 2.4 Natural History Diagnosis Investigations Assessment of severity 3. Pharmacological Management 3.1 3.2 3.3 3.4 3.5 3.6 3.7 3.8 3.9 Nebulised adrenaline β2agonist bronchodilators Ipratropium bromide Antibiotics Corticosteroids Ribavirin Immunoglobulin Analgesics and antipyretics Oral antitussives, expectorants or decongestants 4. Non-pharmacological Management 4.1 Oxygen 4.2 Feeding and Hydration 4.3 Chest Physiotherapy 4.4 Mist, Steam or Nebulised Saline 4.5 Saline drops 4.6 Suctioning 4.7 Apnoea management 4.8 Positioning 4.9 Level of care required 4.10 Observations 4.11 Hospital Infection Control 5. Patient Education and Self-Management 6. Outcomes and Audit 6.1 Process measures 6.2 Outcome measures 7. Dissemination and Implementation of the Guideline 8. Guideline Development Process 8.1 8.2 8.3 8.4 Southern Health Bronchiolitis Guideline Development Methodology Searches Critical Appraisal of Identified Research 9. References Annex 1: Management of Bronchiolitis in Hospital Annex 2: Management of Bronchiolitis in General Practice Annex 3: Normal Parameters for Paediatric Vital Signs Glossary Acronyms and Abbreviations Contents 9 9 12 12 12 14 19 21 21 21 23 23 24 26 27 28 28 29 29 31 34 34 34 35 35 36 37 39 40 42 44 44 44 46 47 47 48 51 57 72 77 78 79 80 80 3 Southern Health Clinical Practice Guideline for the Management of Bronchiolitis in Infants and Children Summary of Recommendations Natural History and Diagnosis Page 9 An infant or child under 18 months presenting with initial signs and 12 symptoms of upper respiratory tract infection followed by cough, tachypnoea, inspiratory crepitations and wheeze is likely to have bronchiolitis. D Consider other diagnoses in infants or children with recurrent bouts of bronchiolitis-like symptoms. 13 D An infant or child with bronchiolitis-like symptoms who responds to treatment with a bronchodilator should be treated according to asthma management guidelines. 13 D The diagnosis of bronchiolitis is clinical. Chest x-rays should not be used to diagnose bronchiolitis. 14 9 Chest x-rays may occasionally be warranted in infants and children where 14 D Chest x-rays should not be routinely performed in infants and children with bronchiolitis. 15 D Consider a chest x-ray in infants and children who have severe respiratory distress, or are at high risk of severe illness. 15 D The diagnosis of bronchiolitis is clinical. Virologic tests should not be used to diagnose bronchiolitis. 16 D Consider virologic testing in infants and children with suspected bronchiolitis if the diagnosis is unclear. 16 D Consider virologic testing in young febrile infants with bronchiolitis. 16 D Virologic tests should not be used to identify the viral aetiology in infants and children with bronchiolitis unless the test result will impact on decisions about clinical management or is required for epidemiologic surveillance. 16 D If PCR testing is available, use nasopharyngeal or nasal swabs to collect specimens for virological testing. If PCR testing is not available, use nasopharyngeal aspirates to collect specimens for virological testing. 17 D Blood counts should not be routinely performed in infants or children with suspected or diagnosed bronchiolitis. 17 D Blood cultures should not be routinely performed in infants or children with bronchiolitis. 18 D Urine cultures should not be routinely performed in infants or children with bronchiolitis. 18 D Blood gas analysis should not be routinely performed in infants or children with bronchiolitis. 19 D Blood gas analysis should be performed in infants or children with lifethreatening bronchiolitis. 19 D Consider blood gas analysis in infants or children with severe bronchiolitis. 19 the diagnosis is uncertain. Introduction 4 Southern Health Clinical Practice Guideline for the Management of Bronchiolitis in Infants and Children Page 9 Infants who are <3 months old or who were born at <36 weeks gestation, 20 and infants or children who have underlying cardiorespiratory disease are at higher risk of more severe disease. Pharmacological Management A Adrenaline should not be routinely used for treatment of bronchiolitis. 21 A β2agonist bronchodilators should not be routinely used for treatment of bronchiolitis. 22 D Consider a trial of a single dose of β2agonist bronchodilators in patients older than 9 months, particularly those with recurrent wheezing. 22 D β2agonist bronchodilators should not be continued if an infant or child does not respond to an initial trial. 22 A Ipratropium bromide should not be routinely used for treatment of bronchiolitis. 23 A Antibiotics should not be routinely used for treatment of bronchiolitis. 24 D Consider antibiotics in infants and children with bronchiolitis who have clinical signs or symptoms of a secondary bacterial infection. 24 A Corticosteroids should not be routinely used for treatment of bronchiolitis. 25 A Ribavirin should not be routinely used for treatment of bronchiolitis. 26 A Immunoglobulin should not be routinely used for treatment of bronchiolitis. 27 28 D Infants and children with bronchiolitis and fever may be treated with paracetamol or ibuprofen to bring their temperature down and reduce irritability. Carefully consider and exclude other potential causes of fever, irritability and pain. D Oral antitussives, expectorants or decongestants should not be routinely used for treatment of bronchiolitis. 28 Non-pharmacological Management D Give oxygen to any infant or child with life-threatening bronchiolitis or oxygen saturations less than 90%. 29 D Consider giving oxygen to an infant or child with moderate or severe bronchiolitis, particularly if aged less than 3 months. 29 D Consider giving oxygen while feeding to an infant or child with mild or moderate bronchiolitis who has increased work of breathing and/or difficulty maintaining oxygenation during feeds. 29 D In infants and children with bronchiolitis receiving oxygen therapy, provide oxygen using the method that causes least distress to the infant or child. If nasal prongs or face masks are used, ensure that infant or child is closely monitored to avoid entanglement. 29 D In infants and children with bronchiolitis receiving oxygen therapy, maintain oxygen saturation levels between 92% and 95%. 30 Introduction 5 Southern Health Clinical Practice Guideline for the Management of Bronchiolitis in Infants and Children Page D In infants and children with bronchiolitis receiving oxygen therapy, administer oxygen at the lowest flow rate required to maintain oxygen saturations between 92 and 95%. 30 D In infants and children with bronchiolitis receiving oxygen, assess oxygen saturation, respiratory rate, heart rate and accessory muscle use hourly. 30 D In infants and children with bronchiolitis receiving oxygen therapy at a rate >0.5l/min continuously monitor oxygen saturation. 30 D In infants and children with bronchiolitis in whom oxygen is being ceased, assess oxygen saturation, respiratory rate, heart rate and accessory muscle use initially hourly and then less frequently as observations are stable or improving. 30 D In infants and children with bronchiolitis decisions management of oxygen therapy can be made by nursing staff, in line with this guideline, and medical staff should be informed. Nurses should consult with medical staff if the infant or child deteriorates. 30 D Infants or children with mild or moderate bronchiolitis may continue oral feeding unless it increases their respiratory distress. 31 D Infants or children with severe or life-threatening bronchiolitis should not be offered oral feeds. 31 D In infants and children with bronchiolitis who have signs of circulatory compromise, including hypotension, capillary refill time greater than 4 seconds, or skin pinch retraction time greater than 2 seconds, consult senior paediatric or emergency medical staff to determine fluid management. 31 D Consider nasogastric or intravenous fluids for infants and children with moderate or severe bronchiolitis. 32 D Give intravenous fluids to any infant or child with life-threatening bronchiolitis. 32 D In infants and children with moderate bronchiolitis requiring fluid therapy, provide fluids via nasogastric tube unless work of breathing is increased. 32 D In infants and children with life-threatening bronchiolitis, or with moderate or severe bronchiolitis and increased work of breathing, requiring fluid therapy, provide intravenous fluids. 32 D In infants and children with bronchiolitis receiving nasogastric fluids, give milk (breast milk, formula, cow’s milk, etc as per usual diet). 32 D In infants and children with bronchiolitis receiving intravenous fluids, use a continuous infusion of Glucose 5% and Sodium Chloride 0.9%. 33 D In infants and children with bronchiolitis and no signs of significant dehydration receiving nasogastric or intravenous fluids, provide fluids at 75% of normal maintenance rate. 33 D Infants and children with bronchiolitis and signs of significant dehydration may require fluids at a higher rate. Discuss management with a senior clinician. 33 D Infants and children with bronchiolitis should have blood taken for glucose, urea, electrolytes and bicarbonate if intravenous fluids are being provided. 33 Introduction 6 Southern Health Clinical Practice Guideline for the Management of Bronchiolitis in Infants and Children Page D Infants and children with bronchiolitis with significantly abnormal electrolytes should be managed in consultation with a senior clinician. 33 D Infants and children with bronchiolitis with significantly abnormal electrolytes and those receiving intravenous fluid therapy for more than 24 hours, should have their plasma biochemistry reassessed at least daily according to results and the clinical situation. 33 A Chest physiotherapy should not be routinely used for treatment of bronchiolitis. 34 D Mist, steam and nebulised saline should not be routinely used for treatment of bronchiolitis. 34 D Saline nasal drops should be trialled in infants and children with bronchiolitis who have nasal congestion, particularly before feeds. 34 D Nasal suctioning may be trialled in infants or children with bronchiolitis who have nasal congestion. 35 D Infants and children with bronchiolitis who are at increased risk of apnoea as a result of age less than 3 months, premature birth or previous apnoea should be closely monitored. 35 D Infants and children with bronchiolitis-related apnoea should be managed in consultation with senior paediatric or emergency medical staff. 35 C 36 Infants and children with bronchiolitis should be allowed to adopt the position they find most comfortable. Infants unable to position themselves may be placed in either a prone or supine position, with head slightly elevated. Infants and children with bronchiolitis who are placed in a prone position should have continuous pulse oximetry monitoring, and the reasons for the position should be explained to the parent. D Infants and children with mild bronchiolitis may be managed by a general practitioner and sent home for observation if the GP is confident the parent/carer can adequately manage the infant/child’s illness. 37 D Infants and children with moderate bronchiolitis who do not require oxygen or fluid therapy may be managed by a general practitioner, otherwise the infant or child should be sent to hospital. 37 D An ambulance should be called for infants and children with severe or life threatening bronchiolitis. 37 D If a general practitioner is not available, infants and children with moderate bronchiolitis should be taken to a hospital emergency department. 38 D All infants or children with severe or life-threatening bronchiolitis should be sent by ambulance to an emergency department. 38 D All infants or children with life-threatening bronchiolitis or severe bronchiolitis requiring ongoing oxygen therapy at levels above 40%, should be managed in conjunction with staff from the Intensive Care Unit. 38 D Infants and children with bronchiolitis can be discharged from the Intensive Care Unit to the paediatric ward when they have no signs of life-threatening bronchiolitis. 38 Introduction 7 Southern Health Clinical Practice Guideline for the Management of Bronchiolitis in Infants and Children D Infants and children with bronchiolitis can be discharged from hospital when they have no signs of moderate bronchiolitis requiring oxygen or fluid therapy; severe or life-threatening bronchiolitis. 38 D A letter should be sent by fax, mail or email to the GP (and any relevant specialists) of any infant or child presenting with bronchiolitis to hospital. 39 D On discharge the family should be given information on when to seek further medical attention, and a copy of the discharge summary. 39 D Infants and children with bronchiolitis should be reviewed by their GP 2 days after initial GP or ED presentation or discharge from hospital, or at any time if their clinical condition deteriorates. 39 D For infants and children with mild bronchiolitis, assess the following clinical signs at least once every four hours, taking care not to distress the infant or child: • Accessory muscle use, tracheal tug or chest wall retraction • Respiratory rate • Oxygen saturation • Heart rate. 40 D For infants and children with moderate bronchiolitis, assess the following clinical signs at least once every two hours, taking care not to distress the infant or child: • Accessory muscle use, tracheal tug or chest wall retraction • Respiratory rate • Oxygen saturation • Heart rate. 40 40 D Infants and children with life-threatening or severe bronchiolitis are likely to require continuous monitoring and constant supervision. Assess the following clinical signs at least once every 30 minutes and more frequently if the infant or child’s condition is deteriorating: • Accessory muscle use, tracheal tug or chest wall retraction • Respiratory rate • Oxygen saturation • Heart rate. 41 D Infants and children with bronchiolitis at Southern Health, regardless of RSV status, should be managed according to the Southern Health Infection Control Guidelines following Standard, Droplet and Contact Precautions. 41 D Infants and children with bronchiolitis can be accommodated in shared rooms where single rooms are not available. 41 D Where infants and children with bronchiolitis are accommodated in shared rooms, infants and children and any associated equipment or toys should be separated by at least two metres (a radius of one meter around each infant or child). 41 9 Take special care in infants and children with bronchiolitis who have underlying chronic illnesses which might make them more vulnerable to infection. Introduction 8 Southern Health Clinical Practice Guideline for the Management of Bronchiolitis in Infants and Children 1. Introduction This Guideline was developed by the Health for Kids in the South East Bronchiolitis Guideline Development Group at Southern Health in 2005. The process undertaken to develop this guideline was evidence-based. Initially a search was undertaken to identify existing evidence-based guidelines which could be adapted for local use. No high quality evidencebased guidelines for the management of bronchiolitis (as assessed by the AGREE Criteria117) were identified. However an Evidence Report/Technology Assessment “Management of Bronchiolitis in Infants and Children”118 published by the Agency for Healthcare Research and Quality (AHRQ) in January 2003 was identified and this report formed the basis for much of the content in this guideline. A multidisciplinary Bronchiolitis Guideline Development Group (GDG) was convened that included representation from all relevant clinical areas, nursing and medical staff, as well as consumer representatives, a General Practitioner and specialists in evidence-based practice and guideline development. Chapter 7 provides further details of the composition of the GDG. The GDG created a list of clinical questions that should be addressed in a guideline for the management of bronchiolitis, and systematic searches were undertaken to identify evidence to answer these questions. Where evidence was found the GDG made recommendations based on this evidence, integrated with clinical expertise and consumer preferences. Where evidence was not found to answer a clinical question the GDG made a consensus recommendation based on clinical expertise and consumer preferences. The levels of evidence found, and grades of recommendation made are identified in the text of the guideline, as described in Table 1. A full description of the development process can be found in Chapter 7. It is intended that this guideline be updated every 2 years, to reflect changes in the available evidence and any relevant local changes. This guideline will therefore be due for review in October 2008. 1.1 Statement Of Intent This guideline has been developed to ensure infants and children with bronchiolitis receive the best possible care, based on the best available evidence integrated with clinical expertise and parent/carer preferences. The guideline aims to provide clinicians with recommendations for the management of infants and children presenting with bronchiolitis and to promote consistency of care for infants and children with bronchiolitis in primary care and hospital settings. The guideline also aims to form the foundation of information for parents and carers of infants and children with bronchiolitis. Introduction 9 Southern Health Clinical Practice Guideline for the Management of Bronchiolitis in Infants and Children Guidelines are a tool used to improve patient care and do not replace the central role of clinical expertise and judgement in determining appropriate patient care. Clinicians should apply this guideline in the context of the individual patient. Variations from this guideline should be documented in the patient’s medical record at the time the relevant decision is made. The recommendations in this guideline were based on the best evidence available at the time of writing, and should be read with an awareness of any more recent evidence. A number of supporting documents have been developed to facilitate the implementation of the recommendations of this guideline into practice. These include a one page decision support algorithm for General Practitioners and hospital staff, an evidence-based clinical path which will form the medical record for infants and children presenting at Southern Health hospitals with bronchiolitis, and evidence-based information for parents and carers of infants and children with bronchiolitis. These documents are available on the Health for Kids website at http://www.mihsr.monash.org/hfk/ Guideline Exclusions This guideline does not apply to: • children who are more than 18 months of age • infants or children with pre-existing airway abnormalities including cystic fibrosis • infants or children with cyanotic cardiac anomalies • infants or children admitted to the intensive care unit. Clinicians should also take extra caution and consult with appropriate specialist clinicians when caring for: • very young infants • infants or children born prematurely • infants or children with significant relevant comorbidities including chronic lung disease • infants or children with chronic illnesses. Take special care to exclude other diagnoses in infants and children presenting with recurrent wheezing. Guideline Users This guideline is intended for use by clinicians involved in the care and management of infants and children with bronchiolitis in general practice, emergency departments and paediatric wards. It has been primarily developed for use in Southern Health hospitals and by clinicians practicing within the Southern Health catchment area in south east Melbourne, Australia. Adaptation for local use may be necessary in other contexts. Introduction 10 Southern Health Clinical Practice Guideline for the Management of Bronchiolitis in Infants and Children Table 1: KEY TO EVIDENCE STATEMENTS AND GRADES OF RECOMMENDATIONS 163 LEVELS OF EVIDENCE 1++ High quality meta-analyses, systematic reviews of randomised controlled trials (RCTs), or RCTs with a very low risk of bias 1+ Well conducted meta-analyses, systematic reviews of RCTs, or RCTs with a low risk of bias 1- Meta-analyses, systematic reviews of RCTs, or RCTs with a high risk of bias 2++ High quality systematic reviews of case control or cohort studies. High quality case control or cohort studies with a very low risk of confounding or bias and a high probability that the relationship is causal 2+ Well conducted case control or cohort studies with a low risk of confounding or bias and a moderate probability that the relationship is causal 2- Case control or cohort studies with a high risk of confounding or bias and a significant risk that the relationship is not causal 3 Non-analytic studies, e.g. case reports, case series 4 Expert opinion GRADES OF RECOMENDATION Note: The grade of recommendation relates to the strength of the evidence on which the recommendation is based. It does not reflect the clinical importance of the recommendation. A At least one meta-analysis, systematic review of RCTs, or RCT rated as 1++ and directly applicable to the target population; or A body of evidence consisting principally of studies rated as 1+, directly applicable to the target population, and demonstrating overall consistency of results B A body of evidence including studies rated as 2++, directly applicable to the target population, and demonstrating overall consistency of results; or Extrapolated evidence from studies rated 1++ or 1+ C A body of evidence including studies rated as 2+, directly applicable to the target population, and demonstrating overall consistency of results; or Extrapolated evidence from studies rated 2++ D Evidence level 3 or 4; or Extrapolated evidence from studies rated 2+ GOOD PRACTICE POINTS 9 Recommended best practice based on the clinical experience of the guideline development group Introduction 11 Southern Health Clinical Practice Guideline for the Management of Bronchiolitis in Infants and Children 2. Natural History and Diagnosis 2.1 Natural History Bronchiolitis is a viral infection of the respiratory tract.1 It is characterised by: • acute inflammation, oedema, and necrosis of epithelial cells lining the bronchioles; • increased mucus production; • and bronchospasm; all of which contribute to obstruction of the small airways. Infants and children with bronchiolitis often present with features of both upper and lower respiratory tract infection including rhinitis, rapid breathing (tachypnoea), wheezing, cough, crackles, use of accessory muscles and nasal flaring. Bronchiolitis is the most common lower respiratory tract infection in infants. In Australasia, Europe and North America up to 3 percent of all children in their first year of life are hospitalised with bronchiolitis.1 Most infants and young children experience only a mild form of bronchiolitis, and are managed on an outpatient basis. In Australia approximately 13,500 children are admitted to hospital with bronchiolitis each year. More than 80% of Australian children admitted with bronchiolitis are less than 1 year old.119 Bronchiolitis is commonly caused by respiratory syncytial virus (RSV) and may also be caused by parainfluenza, adenovirus and influenza.4 Most bronchiolitis occurs in autumn and winter, however because some types of parainfluenza virus are present in other months, bronchiolitis can be seen year round. Duration of illness has been investigated in two studies.120,121 In both studies the median duration of illness was 2 weeks, and approximately 20% of patients had symptoms lasting longer than 3 weeks. 2.2 Diagnosis The diagnosis of bronchiolitis is clinical - no diagnostic test confirms the disease. There is very little research evidence on which to establish evidence-based recommendations for the diagnosis of bronchiolitis. However, there is a consensus of opinion in the medical literature that an infant presenting with initial signs and symptoms of upper respiratory tract infection followed by cough, tachypnoea, inspiratory crepitations and wheeze is likely to have bronchiolitis. 9 An infant or child under 18 months presenting with initial signs and symptoms of upper respiratory tract infection followed by cough, tachypnoea, inspiratory crepitations and wheeze is likely to have bronchiolitis. Natural History and Diagnosis 12 Southern Health Clinical Practice Guideline for the Management of Bronchiolitis in Infants and Children Fever, hypoxia, and accessory muscle use may also be present in an infant or child with bronchiolitis. Chest examination may be clear, but a prolonged expiratory phase with wheeze, rhonchi and crepitations may be found. Infants and children with bronchiolitis may also have dehydration resulting from the combination of difficulty feeding and increased insensible water losses due to tachypnoea. 2.2.1 Alternative diagnoses There is very little research evidence on which to establish evidence-based recommendations for alternate diagnoses for infants and children with suspected bronchiolitis. The GDG agreed that in an infant or child with bronchiolitis-like signs and symptoms conditions including asthma, pneumonia, whooping cough, cystic fibrosis, congestive heart failure, and an inhaled foreign body should be excluded. The GDG agreed that bronchiolitis should also be distinguished from transient wheezing of childhood, a condition characterised by recurrent bouts of wheezing, in the absence of an underlying structural abnormality, in an otherwise well infant or child. In most infants and children with transient wheezing the symptoms do not cause significant respiratory distress and resolve in the first three to five years of life as the airways mature.122 D Consider other diagnoses in infants or children with recurrent bouts of bronchiolitis-like symptoms. 2.2.1.1 Asthma An infant or child with recurrent wheezing, particularly in the absence of symptoms of a viral infection or at an older age may have asthma. It is often difficult to distinguish between the infant or child who is wheezing as a result of a viral infection of the bronchioles (bronchiolitis) and the infant or child who is wheezing because a viral infection has caused an acute exacerbation of asthma. An infant or child with bronchiolitis-like symptoms who responds to treatment with a bronchodilator such as salbutamol is likely to have asthma. D An infant or child with bronchiolitis-like symptoms who responds to treatment with a bronchodilator should be treated according to asthma management guidelines. Natural History and Diagnosis 13 Southern Health Clinical Practice Guideline for the Management of Bronchiolitis in Infants and Children 2.2.1.2 Pneumonia An infant or child with bronchiolitis may also have viral pneumonia. Differentiating between the two entities is difficult and largely unnecessary as treatment in either case is supportive. An infant or child with localising signs or more severe symptoms may have bacterial pneumonia. 2.2.1.3 Pertussis (Whooping cough) An infant or child who presents with cough as the predominant symptom and does not have wheeze, fever or crackles may have pertussis. Pertussis should particularly be considered in an infant or child who is unimmunised, or partially immunised. Not all infants or children with pertussis have the characteristic whoop, but the presence of a whoop-type cough makes pertussis very likely. 2.2.1.4 Cystic Fibrosis An infant or child with persistent, or repeated and prolonged, respiratory symptoms and failure to thrive may have cystic fibrosis. 2.2.1.5 Congestive heart failure An infant or child with congestive heart failure may present with signs indistinguishable from bronchiolitis. A diagnosis of congestive heart failure is more likely in the presence of a cardiac murmur, failure to thrive, oedema or a history of slow onset of symptoms. 2.2.1.6 Inhaled foreign body A previously well infant or child who has sudden onset of symptoms, history of a coughing or choking episode, expiratory wheeze, loss of voice, or differential air entry may have an inhaled foreign body. 2.3 Investigations 2.3.1 Chest radiographs 2.3.1.1 Diagnosis No studies were identified which investigated the accuracy of chest x-rays in diagnosing bronchiolitis. D The diagnosis of bronchiolitis is clinical. Chest x-rays should not be used to diagnose bronchiolitis. 9 Chest x-rays may occasionally be warranted in infants and children where the diagnosis is uncertain. Natural History and Diagnosis 14 Southern Health Clinical Practice Guideline for the Management of Bronchiolitis in Infants and Children 2.3.1.2 Assessment and management Many infants or children with bronchiolitis have abnormalities on chest xrays, 24,25,32,36-45 however there is little evidence to demonstrate that chest x-ray findings correlate well with disease severity. Four studies were identified which examined the relationship between x-ray abnormalities and disease severity. In one study32 infants with atelectasis were 2.7 times more likely (95% CI: 1.97, 3.70) to have severe disease than those without this x-ray finding. This association persisted when it was included in a multivariable analysis. In contrast, a second study36 demonstrated no correlation between chest xray findings and disease severity as measured by a clinical severity scoring system. 2- Two studies43, 123 including more than 17,000 infants and children with a discharge diagnosis of bronchiolitis found that chest radiograph was associated with increased antibiotic use and increased length of stay. These data cannot be shown to be causal, and the patients receiving xrays may well comprise a group with more severe illness. The authors suggest that the non-specific x-ray findings common to bronchiolitis may lead clinicians to treat patients with antibiotics “just in case”. The effectiveness of antibiotic treatment was not examined in either of these studies. 2- These data suggest that in most cases of bronchiolitis, chest x-rays offer no information that is likely to improve treatment and may lead to inappropriate use of antibiotics. Therefore the GDG agreed that they should not be routinely performed. D Chest x-rays should not be routinely performed in infants and children with bronchiolitis. D Consider a chest x-ray in infants and children who have severe respiratory distress, or are at high risk of severe illness. Infants and children at high risk of severe illness are outlined in section 2.4. 2.3.2 Virologic tests 2.3.2.1 Diagnosis Bronchiolitis can be caused by a number of different viruses and identification of the viral aetiology is not necessary for diagnosis. Many studies have attempted to identify the aetiology of bronchiolitis. The proportion of cases caused by RSV has been found to be between 26 percent and 95 percent, however we were unable to identify any studies reporting viral aetiology of bronchiolitis in Australia. It has been suggested that bronchiolitis is more likely to be due to RSV during winter. Natural History and Diagnosis 15 Southern Health Clinical Practice Guideline for the Management of Bronchiolitis in Infants and Children D The diagnosis of bronchiolitis is clinical. Virologic tests should not be used to diagnose bronchiolitis. D Consider virologic testing in infants and children with suspected bronchiolitis if the diagnosis is unclear. 2.3.2.2 Assessment and management RSV testing may be justified for assessment or management of an infant or child with bronchiolitis in several situations: • In a young, febrile infant to support a clinician’s diagnosis and aid ongoing management • Where RSV-specific therapies are being evaluated for effectiveness • For surveillance of lower respiratory tract infections in infants One study was identified which examined the risk of bacterial infection (urinary tract infection, bacteraemia or meningitis) in febrile infants aged ≤60 days with bronchiolitis.126 In this study, RSV positive infants were less likely to have a bacterial infection than RSV negative infants (7% vs 12.5%, RR=0.6; 95%CI 0.3, 0.9). These results suggest that while a positive RSV test makes bacterial infection less likely, such a test cannot be used to definitively rule out bacterial infection. 2+ D Consider virologic testing in young febrile infants with bronchiolitis. No studies were identified which examined whether RSV testing affects clinical management of infants and children with bronchiolitis. Many institutions test all infants being admitted to the hospital, presumably to decrease nosocomial RSV infections by segregating RSV positive infants and children. However, no studies were identified which examined the effects of cohort segregation in preventing nosocomial transmission of bronchiolitis. In the absence of evidence the GDG agreed to the following recommendation: D Virologic tests should not be used to identify the viral aetiology in infants and children with bronchiolitis unless the test result will impact on decisions about clinical management or is required for epidemiologic surveillance. Natural History and Diagnosis 16 Southern Health Clinical Practice Guideline for the Management of Bronchiolitis in Infants and Children 2.3.2.3 Comparison of methods of specimen collection Two studies were identified which compared different methods of specimen collection for virological tests. The first study26 demonstrated that viral culture, enzyme immunoassays, and immunofluorescence assays all yielded positive results more often when performed on nasopharyngeal aspirates (NPAs) than when performed on nasopharyngeal swabs. Similarly the second study124 found that in 88 children hospitalised for suspected bronchiolitis, in 86% of cases nasal swabs and NPAs produced the same result (n=76, 21 positive, 55 negative). However in 11 cases (14%) nasal swabs were negative when NPAs were positive and in 1 case, the nasal swab was positive when the NPA was negative. Consultation with the Victorian Infectious Diseases Reference Laboratory, Southern Cross Pathology Australia and the Southern Health Microbiology Unit highlighted that the sensitivity of polymerase chain reaction (PCR) testing of nasal swabs is high enough to make this the preferred option, where PCR is available. However where PCR testing is not available, NPAs are the preferred method of specimen collection as enzyme immunoassays, and immunofluorescence assays are not very sensitive when used on swabs, as discussed above. D If PCR testing is available, use nasopharyngeal or nasal swabs to collect specimens for virological testing. If PCR testing is not available, use nasopharyngeal aspirates to collect specimens for virological testing. At Southern Health, enzyme immunoassays, or immunofluorescence assays and cultures are used for routine RSV testing – and so NPAs are the preferred method of specimen collection. Results of routine RSV tests are usually available on the same day. PCR testing can be arranged by special request however the tests are not carried out on-site and results of the tests are not usually available for several days. 2.3.3 Blood counts No studies were found which examined the value of blood cell counts in infants or children with bronchiolitis. One study was found which examined whether blood cell counts differed between infants with RSV lower respiratory tract infection (bronchiolitis or pneumonia) with a concurrent bacterial infection and those without.125 The authors report that there was no statistically significant difference in the mean white blood cell count between patients with a positive bacterial culture and those without (14,500 ± 7,500 cells/ml compared with 11,900 ± 5,200 cells/ml, P=0.06). D Blood counts should not be routinely performed in infants or children with suspected or diagnosed bronchiolitis. Natural History and Diagnosis 17 Southern Health Clinical Practice Guideline for the Management of Bronchiolitis in Infants and Children 2.3.4 Blood and urine cultures Ten studies were found which investigated the incidence of bacterial infections as identified by blood or urine cultures in infants or children with a clinical diagnosis of bronchiolitis.125-134 Two studies125,129 included only RSV positive children or infants, and seven125,126,128,129,131,133,134 only reported data from febrile children or infants. No positive blood cultures were found in seven of the ten studies, including a total of 1456 children or infants. 126-130,133,134 The remaining three studies report positive blood cultures in 0.4% (2/470),125 0.2% (1/411)131 and 0.7% (1/140) 132 of children or infants. These data suggest that concurrent bacteraemia is rare in infants or children with bronchiolitis and routine blood cultures are not required. D Blood cultures should not be routinely performed in infants or children with bronchiolitis. Six studies report the results of urine cultures in infants or children with bronchiolitis.125,126,128,130,132,133 • One of these studies reported no positive urine cultures (0/68)130, • Three studies found that 2% of urine cultures were positive (2/106133, 3/140132, 6/273128), • One study found that 6.5% of urine cultures were positive (10/156)126 • One study found that 12% of urine cultures were positive (28/234).125 The variation between results of these studies cannot be accounted for by differing definition of a positive urine culture (though this variedly widely) or differing sample collection, as all of these studies used either suprapubic aspiration or catheterised samples. Some of the positive cultures may represent asymptomatic bacteruria. No studies were identified which examined the impact on clinical outcome of performing a urine culture. Routine urine culture is unlikely to be helpful in infants or children with bronchiolitis in whom sepsis is not suspected. D Urine cultures should not be routinely performed in infants or children with bronchiolitis. Natural History and Diagnosis 18 Southern Health Clinical Practice Guideline for the Management of Bronchiolitis in Infants and Children 2.3.5 Blood gas analysis No studies were identified which examined the impact of arterial blood gas analysis on the management of infants or children with bronchiolitis. In the absence of evidence about the role of arterial blood gas analysis, the GDG agreed to the following recommendations: D Blood gas analysis should not be routinely performed in infants or children with bronchiolitis. D Blood gas analysis should be performed in infants or children with lifethreatening bronchiolitis. D Consider blood gas analysis in infants or children with severe bronchiolitis. 2.4 Assessment of severity 2.4.1 Clinical signs and symptoms Seven studies were found which examined the relationship between severity of bronchiolitis and clinical indicators.137-143 The studies used a number of different methods to assess the underlying severity of disease. These included: • Oxygen saturation on presentation (measured by pulse oximetry or arterial blood gas analysis) • Need for: o Oxygen supplementation o Mechanical ventilation o Hospital admission o Intensive care unit (ICU) admission These differing methods of categorising severity, as well as the wide variety of clinical indicators examined, make it difficult to synthesise the results. In all the studies in which they were assessed, low oxygen saturation at presentation,139,141-3 young age at presentation,137,139,140,142-3 prematurity,139,140,143 cyanosis141-2 and increased work of breathing (including alone and in various combinations; increased respiratory rate, accessory muscle use, chest wall retraction, recessions, nasal flare and/or grunting)137, 139,141-3 were associated with increased disease severity. In the one study in which they were assessed, crepitations on auscultation were associated with more severe disease. 142 “Toxic” appearance was also associated with more severe disease in the one study143 in which it was assessed as was dehydration.137 Increased heart rate was associated with more severe disease in one137 of the four139,141-2 studies in which it was assessed. Fever was associated with increased severity of disease in one138 of the three139,142 studies in which it was assessed. The clinical signs and symptoms in the table below are based on the above described evidence and the consensus opinion of the GDG. Natural History and Diagnosis 19 Southern Health Clinical Practice Guideline for the Management of Bronchiolitis in Infants and Children Table 2. Assessment of severity of disease Mild Severity of disease Moderate Severe Any one or more of these features: • Normal respiratory rate • Subtle or no accessory muscle use • Increased respiratory rate • Minor accessory muscle use • Markedly increased respiratory rate • Moderate/marked accessory muscle use • Nasal flare or grunting • Normal heart rate • Increased heart rate • Markedly increased heart rate • Able to feed • Minor dehydration • Some limitation of ability to feed • Marked dehydration • Unable to feed • Crackles • Toxic appearance • Sweaty • Irritable • SpO2 90-95% • SpO2 <90% • SpO2>95% Life threatening • Maximal accessory muscle use/exhaustion • Poor respiratory effort • Apnoeas • Cyanosis N.B. Infants or children with symptoms across categories should be treated according to their most severe features. Treatment should not be based on a child’s oxygen saturation alone. When assessing severity of disease, it is important to note that infants who are <3 months old or who were born at <36 weeks gestation, and infants who have underlying cardiorespiratory disease are at higher risk of severe bronchiolitis. 9 Infants who are <3 months old or who were born at <36 weeks gestation, and infants or children who have underlying cardiorespiratory disease are at higher risk of more severe disease. Natural History and Diagnosis 20 Southern Health Clinical Practice Guideline for the Management of Bronchiolitis in Infants and Children 3. Pharmacological Management 3.1 Nebulised adrenaline A Cochrane systematic review144 was identified which investigated the effectiveness of nebulised adrenaline in the treatment of bronchiolitis. The review included nine randomised controlled trials (RCTs), with a total of more than 500 infants and children, comparing adrenaline to placebo. One of the RCTs included in the review used subcutaneous adrenaline, which is no longer used in clinical practice; the results of this study are excluded from this discussion. The Cochrane review included studies published up to May 2003 and no more recent RCTs were identified in our searching. Five of the included RCTs investigated inpatient use of adrenaline. In these studies there was no difference between the groups in length of stay, change in clinical score at 30 minutes, change in oxygen saturation at 30 or 60 minutes, heart rate at 30 or 60 minutes, respiratory rate at 30 or 60 minutes or pallor. Patients in the adrenaline group had a slightly greater reduction in clinical score at 30 minutes (standardised mean difference (SMD) -0.52; 95%CI -1.00, -0.03). The clinical scores which were used had scales with between 9 and 17 points. 1+ Three of the included RCTs investigated outpatient or emergency department use of adrenaline. In these studies there was no difference between the adrenaline and control groups in admission rates, change in clinical score at 30 minutes, change in oxygen saturation at 30 minutes or 60 minutes or heart rate at 30 minutes. Small, statistically significant differences favouring the adrenaline group were found in change in clinical score at 60 minutes (SMD -0.81; 95% CI -1.56, -0.07), change in oxygen saturation at 30 minutes (weighted mean difference (WMD) 2.79; 95% CI 1.50, 4.08) and respiratory rate at 30 minutes (WMD -4.54; 95% CI -8.89, -0.19). Heart rate was higher in the adrenaline group at 60 minutes (WMD 11.8; 95% CI 5.2, 18.4). The relatively small size and transitory nature of these effects makes their clinical importance difficult to ascertain. In light of the evidence that adrenaline has no impact on admission rates or length of stay, and has little impact on clinical condition the GDG agreed that: A Adrenaline should not be routinely used for treatment of bronchiolitis. 3.2 β2agonist bronchodilators A systematic review145 was identified which investigated the effectiveness of β2agonist bronchodilators (salbutamol or albuterol) in the treatment of bronchiolitis. The review included 12 RCTs, with a total of more than 1000 infants and children, comparing β2agonist bronchodilators to placebo or control. One RCT identified by the review authors and appraised as being of excellent quality, was not referred to in the results section of the review for reasons that are not clear. The results of this RCT have been added for this discussion. The review included studies published up to November 2002 and no more recent RCTs were identified in our searching. Non-pharmacological Management 21 1+ Southern Health Clinical Practice Guideline for the Management of Bronchiolitis in Infants and Children No differences were found in rate of admission or LOS between the treatment and control groups in any of the seven studies reporting these outcomes. Nine of the included studies found no differences between the treatment and control groups on any measured outcomes, including LOS, change in clinical score, oxygen saturation, respiratory rate and heart rate. Two studies reported short-term improvements in clinical score; at 30 minutes and 60 minutes after treatment in one study and 30 minutes but not 60 minutes after treatment in the second study. Several included studies reported possible harms associated with bronchodilator use. One study reported significantly lower mean decreases in respiratory rate in the control group than in the treatment group. Two studies reported worse oxygenation in the treatment group compared to the control group. Non-statistically significant increases in heart rate and/or decreases in oxygenation were reported in a further five studies. The authors conclude that the evidence does not support the routine use of β2agonist bronchodilators for treating patients with bronchiolitis. In light of the evidence that β2agonist bronchodilators have no impact on admission rates or length of stay, have little impact on clinical condition and may potentially cause harm, the GDG agreed that: A β2agonist bronchodilators should not be routinely used for treatment of bronchiolitis. As discussed in section 2.2.1.1, bronchiolitis and asthma can be difficult to distinguish, particularly in older infants and young children. There is no evidence to determine at what particular age it is appropriate to consider asthma as an alternative diagnosis. Thresholds of between 8 and 12 months have been suggested. In light of this, the consensus recommendation of the GDG was to: D Consider a trial of a single dose of β2agonist bronchodilators in patients older than 9 months, particularly those with recurrent wheezing. As recommended in section 2.2.1.1, infants and children who respond to a trial with β2agonist bronchodilators should be managed according to asthma guidelines. Further to this the GDG agreed to recommend that: D β2agonist bronchodilators should not be continued if an infant or child does not respond to an initial trial. Non-pharmacological Management 22 Southern Health Clinical Practice Guideline for the Management of Bronchiolitis in Infants and Children 3.3 Ipratropium bromide A systematic review145 was identified which investigated the effectiveness of ipratropium bromide in the treatment of bronchiolitis. The review included three RCTs, with a total of more than 200 infants and children, comparing ipratropium bromide to placebo published up to November 2002. No more recent RCTs were identified in our searching. 1+ No differences were found in LOS or clinical outcomes between the treatment and control groups in any of the studies. The authors conclude that there is little evidence to support a routine role for ipratropium bromide in treating patients with bronchiolitis. In line with the evidence that ipratropium bromide has no effect on length of stay or clinical outcomes the GDG agreed that: A Ipratropium bromide should not be routinely used for treatment of bronchiolitis. 3.4 Antibiotics The AHRQ Health Technology Assessment118 did not locate any primary studies of the effect of antibiotics for treatment of bronchiolitis, however they did identify one small RCT evaluating the effectiveness of antibiotics compared to control for lower respiratory infection in which a subset of enrolled patients had bronchiolitis.49 The study included 61 children with an average age at enrolment of approximately one and a half years who were RSV positive.49 The active treatment group received oral ampicillin if under 2 years of age and oral penicillin if over 2 years of age. Penicillin-allergic children were treated with erythromycin. The control group did not receive antibiotic therapy on a routine basis, although seven of 27 children ultimately did receive antibiotics for other reasons such as persistent fever. Primary outcomes included duration of hospitalisation and whether the child was considered “pulmonarily healthy” on day 3, at discharge, and at 3 weeks after treatment. The study groups did not differ significantly on any of these outcomes. The AHRQ report authors conclude that “No evidence suggests that antibacterial antibiotic therapy is an effective treatment for bronchiolitis. Bronchiolitis in infants and children is caused by viruses, primarily RSV. Therefore, no a priori reason exists to assume that antimicrobial agents effective against bacteria would be appropriate treatment for a viral illness. Antibiotic treatment should be reserved for children who develop complications related to subsequent bacterial infection.” Non-pharmacological Management 23 1+ Southern Health Clinical Practice Guideline for the Management of Bronchiolitis in Infants and Children In light of the evidence that antibiotics do not effect length of stay or clinical outcomes in bronchiolitis the GDG agreed that: A Antibiotics should not be routinely used for treatment of bronchiolitis. The GDG noted that a small number of infants and children with bronchiolitis will also have a secondary bacterial infection, which would be suitable for antibiotic treatment. D Consider antibiotics in infants and children with bronchiolitis who have clinical signs or symptoms of a secondary bacterial infection. 3.5 Corticosteroids Our search for evidence on the effectiveness of corticosteroids in bronchiolitis identified two systematic reviews146-7 and two randomised controlled trials148-9 published since the systematic reviews were conducted. Another RCT assessing the effectiveness of corticosteroids in reducing development of asthma after bronchiolitis was identified,150 however the study was published only as an abstract. We attempted to contact the authors however no reply was received. The first systematic review146 was a Cochrane review which aimed to determine whether the use of systemic corticosteroids improved the shortterm clinical profile of infants and young children with bronchiolitis, as compared to infants and young children who received no corticosteroid therapy or placebo. The review excluded studies in patients with recurrent wheezing and studies where infants and young children were intubated and ventilated in the intensive care setting. The review included a total of 1,198 infants and young children aged 0 to 30 months in 13 independent randomised controlled trials, using a variety of corticosteroids of differing doses and durations. Length of hospital stay was the primary outcome in ten studies. Mean LOS varied between studies from two days to 8.3 days. The meta-analysis showed a non-significant effect of treatment on LOS, with a decrease in LOS in infants and young children treated with corticosteroids of 0.38 days (95% CI -0.81 to 0.05). In the three studies which included only RSV positive infants and young children where LOS was reported, the meta-analysis gave a WMD of -0.67 (95% CI -1.11 to -0.24) indicating a shorter LOS for treated infants and young children in this group compared to placebo. Meta-analysis of eight trials measuring the day 3 clinical score showed no statistically significant difference between treatment and control groups. Similarly, no statistically significant differences in respiratory rates or oxygen saturation were found between groups in any of the studies. Three trials reported hospital admission rates. In two of these trials admission rates were non-significantly, but substantially higher in the treatment group, and in the third trial the admission rate was significantly Non-pharmacological Management 24 1+ Southern Health Clinical Practice Guideline for the Management of Bronchiolitis in Infants and Children higher in the placebo group. Meta-analysis found no difference between groups. The authors concluded that widespread use was not recommended. Two RCTs published after the systematic review search date also addressed the use of corticosteroids in this population. The first RCT148 was a well conducted study in 52 infants aged younger than 12 months admitted on an inpatient ward with bronchiolitis. Infants were randomised to receive 1mg/kg oral prednisolone for 5 days or usual care without steroids. Infants were assessed during their hospital stay and then again at 1, 3, 6 and 12 months post discharge. The study found no differences in LOS, time to clinical resolution or duration of oxygen therapy between groups. Likewise there were no differences between treatment and control groups in rates of wheezing at 1, 3, 6 or 12 months post discharge. A second, less well conducted RCT149 aimed to assess the benefit of adding a single dose of 0.6mg/kg dexamethasone or placebo to adrenaline or salbutamol in a four-arm trial in the Emergency Department. Outcomes included heart rate, respiratory rate and clinical score at 120 minutes, 24 hours and 5 days. Unfortunately 42% of the adrenaline plus placebo group and 43% of the salbutamol plus placebo group were lost to follow-up making interpretation of the results of the trial difficult. 1+ 1- No patients in any of the groups were admitted and no differences were found between the groups in retreatment rates. Fifth day Respiratory Distress Assessment Instrument (RDAI) scores were lower in dexamethasone groups than placebo groups, however the clinical importance of this is unclear as there were no differences in any other reported outcomes and the difference between groups was less than one point on the 14 point scale. The second systematic review147 investigated the use of oral or intravenous corticosteroids in mechanically ventilated infants with bronchiolitis. The review included 3 RCTs of corticosteroids in a total of 137 patients. None of the three studies reported a significant reduction in duration of mechanical ventilation with treatment, and the meta-analysis did not find a significant difference between treatment and control groups. Two studies reported duration of hospitalisation. Neither the studies individually, nor the metaanalysis found a significant difference between treatment and control groups. In light of the evidence that corticosteroids have no effect on clinical outcomes in bronchiolitis, and have minimal, if any, impact on length of stay, the GDG agreed that: A Corticosteroids should not be routinely used for treatment of bronchiolitis. Non-pharmacological Management 25 1+ Southern Health Clinical Practice Guideline for the Management of Bronchiolitis in Infants and Children 3.6 Ribavirin Ribavirin is an anti-viral medication that is administered as a continuous aerosol for a number of hours per day. A systematic review145 was identified which investigated the effectiveness of ribavirin in infants and young children with RSV bronchiolitis. The review included 10 RCTs, with a total of 320 patients, and the authors note that the quality of the included trials was generally low. Five studies reported on outcomes such as days of hospitalisation, length of time that a child required more intensive supportive interventions, and duration of illness. Four of these studies found no significant differences with ribavirin treatment compared with saline placebo. The study that did find differences favouring ribavirin in duration of mechanical ventilation and hospitalisation used sterile water in the placebo arm. Sterile water can induce bronchospasm, making the ribavirin treatment seem more effective. Six of 10 studies reported items such as clinical symptoms and clinical scores. Three of the six studies did not find significant differences between the groups. Differences favouring ribavirin were found for hours to improvement in cough and crepitations but not for wheezing or improved feeding in one study. Illness severity scores were better in the ribavirin group compared with the water placebo group on days 1 and 4 but not on days 2 and 3 of treatment in another study. Similarly, another study found better clinical scores in the ribavirin group compared with the saline placebo group on day 3 but not on days 1 and 2 of treatment. The authors concluded that they “did not find evidence that ribavirin use led to consistent or more than transient improvements in clinical outcomes.” Clinical use of ribavirin is likely to also be constrained by its very high cost and the potential risk to health care personnel, as ribavirin is known to be teratogenic and embyrolethal. In the absence of conclusive evidence for effectiveness of ribavirin in bronchiolitis and in light of its high cost and serious potential health risks, the GDG agreed that: A Ribavirin should not be routinely used for treatment of bronchiolitis. Non-pharmacological Management 26 1+ Southern Health Clinical Practice Guideline for the Management of Bronchiolitis in Infants and Children 3.7 Immunoglobulin The AHRQ Health Technology Assessment118 identified two studies examining the use of respiratory syncytial virus immunoglobulin (RSVIG) administered intravenously for treatment of RSV bronchiolitis and we did not identify any more recent studies. The first trial included 101 previously healthy infants under 2 years of age who were hospitalised with moderate to severe RSV positive bronchiolitis and/or pneumonia and followed them for 1 year after the intervention.25 The intervention group received a single dose of 1500 mg/kg IV RSVIG and the control group received 0.5 percent albumin placebo. Mean days of hospitalisation and mean days of mechanical ventilation were not statistically different between the treatment and placebo groups. There was a trend towards a decrease in the mean number of days of ICU admission (3.92 vs. 6.60, P = 0.06). There were no adverse events related to RSVIG therapy. The study did not include enough patients to detect a difference in duration of hospitalisation of less than 35 percent. 1+ The second trial included 107 high-risk infants under 2 years of age with RSV positive bronchiolitis who had severe BPD, other serious chronic lung disease, congenital heart disease or who had been premature at under 32 weeks gestation with a current age of less than 6 months.41 Infants were randomised to 1500 mg/kg IV RSVIG or albumin placebo and were followed into the next RSV season to assess possible harms, including whether there was any increased risk of more severe RSV disease in children who developed the disease in the second season. No significant difference was noted between the groups in the primary outcome of duration of hospitalisation. No significant differences were reported for secondary outcomes such as duration of ICU admission, duration of mechanical ventilation, need for supplemental oxygen, change in respiratory scores, use of additional medications (bronchodilators, ribavirin, or steroids), development of RSV bronchiolitis in the subsequent season, or readmission during the subsequent season. Some baseline differences between the study groups could have contributed to the negative findings of this study. The RSVIG group had higher entry respiratory scores and more severe disease episodes than the placebo group. Forty-seven percent and 28 percent, respectively required ICU admission, and 31 percent and 18 percent needed mechanical ventilation. 1+ In the absence of evidence for effectiveness of immunoglobulin for the treatment of bronchiolitis, the GDG agreed that: A Immunoglobulin should not be routinely used for treatment of bronchiolitis. Non-pharmacological Management 27 Southern Health Clinical Practice Guideline for the Management of Bronchiolitis in Infants and Children 3.8 Analgesics and antipyretics No studies were identified which examined the effectiveness of analgesics or antipyretics in infants or children with bronchiolitis. One RCT152 was found which compared paracetamol with ibuprofen in 27,065 febrile infants and children aged less than two years, including more than 1,600 with lower respiratory tract infections. In the participants with bronchiolitis or asthma, there was no difference in hospitalisation rate between paracetamol and ibuprofen groups. 1+ Analysis of the entire 27,065 cohort found that there were no infants or children hospitalised for acute renal failure, anaphylaxis or Reye’s syndrome. Three children (all in the ibuprofen group) were hospitalised with evidence of gastrointestinal bleeding. The bleeds were not severe and resolved with conservative management. The GDG noted that some clinicians are concerned that analgesics and antipyretics may potentially mask clinically important symptoms, or that reducing fever may not be appropriate as it may be a physiologically important response to infection. Equally, other clinicians believe that reducing fever can lead to increased appetite, decreased irritability and, therefore, potentially better outcomes. The GDG noted that analgesics and antipyretics are not treatments for bronchiolitis as such, but may be useful adjuncts to treatment, by decreasing fever and irritability. In the absence of evidence the GDG agreed that paracetamol or ibuprofen may be useful in infants or children with bronchiolitis, but that clinicians must carefully consider and exclude other potential causes of fever, irritability and pain before giving these medications. D Infants and children with bronchiolitis and fever may be treated with paracetamol or ibuprofen to bring their temperature down and reduce irritability. Carefully consider and exclude other potential causes of fever, irritability and pain. 3.9 Oral antitussives, expectorants or decongestants No studies were identified which examined the safety or effectiveness of oral antitussives, expectorants or decongestants in infants or children with bronchiolitis. In the absence of evidence the GDG agreed that: D Oral antitussives, expectorants or decongestants should not be routinely used for treatment of bronchiolitis. Non-pharmacological Management 28 Southern Health Clinical Practice Guideline for the Management of Bronchiolitis in Infants and Children 4 Non-pharmacological Management 4.1 Oxygen There is little research investigating the effectiveness of oxygen in infants and children with bronchiolitis, however the rationale for its use is clear. 4.1.1 When to commence oxygen There is no evidence to determine what oxygen saturation should be used as a threshold to begin giving oxygen. Thresholds between 90 and 95% have been suggested. Neither is there any evidence to determine whether oxygen should be provided to infants or children who have increased work of breathing but acceptable oxygen saturations. In the absence of evidence the GDG made the following recommendations: D Give oxygen to any infant or child with life-threatening bronchiolitis or oxygen saturations less than 90%. D Consider giving oxygen to an infant or child with moderate or severe bronchiolitis, particularly if aged less than 3 months. The GDG noted that some infants and children with mild or moderate bronchiolitis will have increased work of breathing and/or difficulty maintaining oxygenation during feeds. In the absence of evidence the GDG made the following recommendation: D Consider giving oxygen while feeding to an infant or child with mild or moderate bronchiolitis who has increased work of breathing and/or difficulty maintaining oxygenation during feeds. 4.1.2 Method of delivery of oxygen There is no evidence to determine what method should be used to deliver oxygen to infants and children with bronchiolitis. Methods including nasal prongs, face masks, head boxes and oxygen tents have been used. Each of these methods has strengths and limitations. Head boxes and oxygen tents substantially restrict movement and limit contact between the infant or child and clinicians or family members, potentially causing unnecessary distress to the infant or child. Nasal prongs and face masks remove this difficulty but may be removed by the infant/child, and may also become entangled if the infant/child is not closely monitored. In the absence of evidence the GDG made the following recommendation: D In infants and children with bronchiolitis receiving oxygen therapy, provide oxygen using the method that causes least distress to the infant or child. If nasal prongs or face masks are used, ensure that infant or child is closely monitored to avoid entanglement. Non-pharmacological Management 29 Southern Health Clinical Practice Guideline for the Management of Bronchiolitis in Infants and Children 4.1.3 Saturation level to be maintained on oxygen There is no evidence to determine what optimal oxygen saturation or other clinical indicators should be maintained by oxygen therapy. Oxygen saturations ranging from 90% to 95% have been suggested. In the absence of evidence the GDG made the following consensus recommendation: D In infants and children with bronchiolitis receiving oxygen therapy, maintain oxygen saturation levels between 92% and 95%. There is no evidence to determine when infants or children with bronchiolitis should be weaned off oxygen therapy. In the absence of evidence the GDG made the following recommendation: D In infants and children with bronchiolitis receiving oxygen therapy, administer oxygen at the lowest flow rate required to maintain oxygen saturations between 92 and 95%. 4.1.4 Observations while on oxygen therapy There is no evidence to determine what clinical observations should be undertaken when an infant or child with bronchiolitis is receiving or being weaned off oxygen. In the absence of evidence the GDG made the following consensus recommendations: D In infants and children with bronchiolitis receiving oxygen, assess oxygen saturation, respiratory rate, heart rate and accessory muscle use hourly. D In infants and children with bronchiolitis receiving oxygen therapy at a rate >0.5l/min continuously monitor oxygen saturation. D In infants and children with bronchiolitis in whom oxygen is being ceased, assess oxygen saturation, respiratory rate, heart rate and accessory muscle use initially hourly and then less frequently as observations are stable or improving. 4.1.5 Orders for commencing, weaning and ceasing oxygen There is no evidence to determine who should be responsible for deciding when to commence, wean and cease oxygen. In the absence of evidence the GDG made the following consensus recommendation: D In infants and children with bronchiolitis decisions management of oxygen therapy can be made by nursing staff, in line with this guideline, and medical staff should be informed. Nurses should consult with medical staff if the infant or child deteriorates. Non-pharmacological Management 30 Southern Health Clinical Practice Guideline for the Management of Bronchiolitis in Infants and Children 4.2 Feeding and Hydration Infants and children with bronchiolitis are prone to become dehydrated as a result of the combined effects of poor oral intake and increased water losses due to increased respiratory rate and work of breathing. There is little evidence available to guide decisions about feeding and hydration in infants and children with bronchiolitis. 4.2.1 Oral feeding There is no evidence to determine whether infants or children with bronchiolitis should continue oral feeding while acutely unwell. Oral feeding is important in infants and children with bronchiolitis as it helps to avoid dehydration, however it may also increase respiratory distress, particularly in infants and children with severe or life-threatening bronchiolitis. In the absence of evidence the GDG made the following consensus recommendations: D Infants or children with mild or moderate bronchiolitis may continue oral feeding unless it increases their respiratory distress. D Infants or children with severe or life-threatening bronchiolitis should not be offered oral feeds. 4.2.2 When to commence hydration There is no evidence to establish the most appropriate way of assessing severity of dehydration in infants and children with bronchiolitis. Signs of dehydration may be confounded by respiratory distress in these infants and children. There is also no evidence to suggest how infants and children with bronchiolitis who are severely dehydrated should be managed. In the absence of evidence the GDG made the following consensus recommendation: D In infants and children with bronchiolitis who have signs of circulatory compromise, including hypotension, capillary refill time greater than 4 seconds, or skin pinch retraction time greater than 2 seconds, consult senior paediatric or emergency medical staff to determine fluid management. There is no evidence to determine when infants and children with bronchiolitis should receive nasogastric or intravenous hydration. Infants and children with mild bronchiolitis who are feeding well are unlikely to require intravenous or nasogastric fluids. With increasing respiratory distress, and inability to feed, infants and children with bronchiolitis may need intravenous or nasogastric fluids. Non-pharmacological Management 31 Southern Health Clinical Practice Guideline for the Management of Bronchiolitis in Infants and Children In the absence of evidence the GDG made the following consensus recommendations: D Consider nasogastric or intravenous fluids for infants and children with moderate or severe bronchiolitis. D Give intravenous fluids to any infant or child with life-threatening bronchiolitis. Note: Refer to next section for discussion of why infants and children with life-threatening bronchiolitis should not receive nasogastric fluids. 4.2.3 Methods of hydration There is no evidence to determine whether nasogastric or intravenous fluids are more appropriate for infants and children with bronchiolitis. Historically most authors have suggested intravenous fluids, however more recently authors have suggested using the nasogastric route. There is a concern that the nasogastric tube may increase obstruction of the airway, increasing respiratory distress, particularly in small infants, and also that it may increase the risk of aspiration. However these risks have not been assessed in controlled studies. In the absence of evidence the GDG made the following consensus recommendations: D In infants and children with moderate bronchiolitis requiring fluid therapy, provide fluids via nasogastric tube unless work of breathing is increased. D In infants and children with life-threatening bronchiolitis, or with moderate or severe bronchiolitis and increased work of breathing, requiring fluid therapy, provide intravenous fluids. There is no evidence to determine which fluid should be used for fluid therapy in infants and children with bronchiolitis. In the absence of evidence the GDG made the following consensus recommendation: D In infants and children with bronchiolitis receiving nasogastric fluids, give milk (breast milk, formula, cow’s milk, etc as per usual diet). For infants and children with bronchiolitis receiving intravenous fluids, there is considerable debate in the medical literature about the most appropriate fluid choice. Anti-diuretic hormone secretion is increased in lower respiratory tract infection, and it has been suggested that giving increased (or even normal maintenance) fluids might lead to hyponatraemia. Various approaches have been suggested, including reducing the volume or osmolarity of fluids provided, however none of these have been tested in controlled trials. Non-pharmacological Management 32 Southern Health Clinical Practice Guideline for the Management of Bronchiolitis in Infants and Children In the absence of evidence the GDG decided to recommend practice in line with existing consensus guidelines and local practice. D In infants and children with bronchiolitis receiving intravenous fluids, use a continuous infusion of Glucose 5% and Sodium Chloride 0.9%. A range of rates of fluid therapy have been suggested ranging from 50% to 100% of normal maintenance rates. In the absence of evidence the GDG decided to recommend practice in line with existing consensus guidelines and local practice. D In infants and children with bronchiolitis and no signs of significant dehydration receiving nasogastric or intravenous fluids, provide fluids at 75% of normal maintenance rate. D Infants and children with bronchiolitis and signs of significant dehydration may require fluids at a higher rate. Discuss management with a senior clinician. There is no evidence to determine what plasma biochemistry monitoring is required for infants and children with bronchiolitis who are having fluid therapy. In the absence of evidence the GDG made the following consensus recommendation: D Infants and children with bronchiolitis should have blood taken for glucose, urea, electrolytes and bicarbonate if intravenous fluids are being provided. Most infants and children with bronchiolitis will have mildly abnormal plasma biochemistry (often hyponatraemia resulting from increased antidiuretic hormone secretion as discussed above) which will not require any further intervention. There is no evidence to determine how often plasma biochemistry should be reassessed, or what action should be taken if abnormal levels are identified. In the absence of evidence the GDG made the following consensus recommendations: D Infants and children with bronchiolitis with significantly abnormal electrolytes should be managed in consultation with a senior clinician. D Infants and children with bronchiolitis with significantly abnormal electrolytes and those receiving intravenous fluid therapy for more than 24 hours, should have their plasma biochemistry reassessed at least daily according to results and the clinical situation. Non-pharmacological Management 33 Southern Health Clinical Practice Guideline for the Management of Bronchiolitis in Infants and Children 4.3 Chest Physiotherapy One Cochrane systematic review153 was identified which included studies published before June 2004, and no further RCTs were identified in our searching. The review included 3 RCTs, with a total of 156 participants with acute bronchiolitis aged between 0 and 24 months. Participants were randomised to chest physiotherapy (percussion or vibration techniques were used in all studies) or standard care. The authors note that the quality of the RCTs was generally good, but they were not placebo controlled, and included small numbers of participants. Meta-analysis was not possible due to differences in outcome measures, however no significant differences were found between treatment and control groups for any outcome measures, including change in severity of illness, duration of oxygen supplementation or length of hospital stay. The authors concluded that “vibration and percussion techniques have not been shown to reduce length of hospital stay in acute bronchiolitis or to improve a severity clinical score”. 1+ In light of the absence of evidence for effectiveness of chest physiotherapy on clinical outcomes the GDG made the following consensus recommendation: A Chest physiotherapy should not be routinely used for treatment of bronchiolitis. 4.4 Mist, Steam or Nebulised Saline No studies were identified which investigated the effectiveness of mist, steam or nebulised saline in the treatment of infants and children with bronchiolitis. In the absence of evidence for effectiveness the GDG agreed that: D Mist, steam and nebulised saline should not be routinely used for treatment of bronchiolitis. 4.5 Saline drops It has been suggested that saline nasal drops might ease congestion in infants and children with bronchiolitis – however there is no evidence to determine whether they are effective. In the absence of evidence the GDG agreed that: D Saline nasal drops should be trialled in infants and children with bronchiolitis who have nasal congestion, particularly before feeds. Non-pharmacological Management 34 Southern Health Clinical Practice Guideline for the Management of Bronchiolitis in Infants and Children 4.6 Suctioning It has been suggested that nasal suctioning might help ease congestion in infants and children with bronchiolitis – however there is no evidence to determine whether it is effective. In the absence of evidence the GDG made the following consensus recommendation: D Nasal suctioning may be trialled in infants or children with bronchiolitis who have nasal congestion. 4.7 Apnoea management There is very little evidence to guide the management of infants and children with apnoea secondary to bronchiolitis. Four case-control studies were identified which reported incidence of apnoea associated with respiratory syncytial virus infection (a combination of infants with either bronchiolitis or pneumonia were included in all studies) varying between 16 and 21 percent.154-157 Young age (less than 3 months) was the only factor consistently related with apnoea in infants and children with RSV in the four studies identified. Three studies reported that prematurity also increased the risk of apnoea.155-157 One study found that infants and children with bronchiolitis and recurrent apnoea were at greater risk for mechanical ventilation.154 2- In light of the minimal evidence available the GDG made the following consensus recommendation: D Infants and children with bronchiolitis who are at increased risk of apnoea as a result of age less than 3 months, premature birth or previous apnoea should be closely monitored. A small number of case series were identified which investigated the role of methylxanthines (caffeine, aminophylline, theophylline) in the treatment of infants and children with bronchiolitis related apnoea.158-161 These studies do not provide evidence to guide treatment, but suggest that randomised controlled trials are warranted to further evaluate the effectiveness of these agents. In the absence of evidence the GDG made the following consensus recommendation: D Infants and children with bronchiolitis-related apnoea should be managed in consultation with senior paediatric or emergency medical staff. Non-pharmacological Management 35 Southern Health Clinical Practice Guideline for the Management of Bronchiolitis in Infants and Children 4.8 Positioning A Cochrane systematic review162 was identified that investigated the impact of positioning (prone, supine, lateral and head elevated) on measures of respiratory distress in infants and children. The review included one RCT of prone versus supine positioning in 17 infants with bronchiolitis. This RCT did not find a significant difference between prone and supine positions. It is likely that this study did not have a large enough sample size to detect a clinically important difference between groups. In the meta-analysis of all included trials, prone positioning was significantly more beneficial than supine positioning in terms of oxygen saturation, partial pressure of arterial oxygen, oxygenation index, thoracoabdominal synchrony, and episodes of desaturation. There were no statistically significant differences between any other positions. The review included three very small studies (n=12, 17 and 17) which investigated the impact of elevation. None of these studies found a significant difference between elevated and flat positioning (supine, prone or lateral). The three studies reported different outcomes and their results could not be combined. It is important to note that the meta-analysis included studies in: o 322 preterm neonates (228 of which were mechanically ventilated), o 49 newborn infants (3 mechanically ventilated) and o 65 infants and children aged 1 month – 16 years (20 mechanically ventilated). The results of the meta-analysis are therefore unlikely to be generalisable to infants and children with bronchiolitis. It is also important to note that prone positioning increases the risk of Sudden Infant Death Syndrome, and for this reason, infants and children with bronchiolitis who are placed in a prone position should have continuous pulse oximetry monitoring. In the absence of clear evidence the GDG agreed that: C Infants and children with bronchiolitis should be allowed to adopt the position they find most comfortable. Infants unable to position themselves may be placed in either a prone or supine position, with head slightly elevated. Infants and children with bronchiolitis who are placed in a prone position should have continuous pulse oximetry monitoring, and the reasons for the position should be explained to the parent. Non-pharmacological Management 36 1- Southern Health Clinical Practice Guideline for the Management of Bronchiolitis in Infants and Children 4.9 Level of care required Note: for details on levels of severity referred to in these sections see Table 2 on Page 17 There is no evidence to determine when infants and children with bronchiolitis should be referred to particular levels of medical care. In the absence of evidence the GDG agreed to the following recommendations: 4.9.1 General Practitioner Most infants and children with signs of mild and some with moderate bronchiolitis can be adequately managed by a general practitioner. D Infants and children with mild bronchiolitis may be managed by a general practitioner and sent home for observation if the GP is confident the parent/carer can adequately manage the infant/child’s illness. D Infants and children with moderate bronchiolitis who do not require oxygen or fluid therapy may be managed by a general practitioner, otherwise the infant or child should be sent to hospital. 4.9.2 Ambulance There is no evidence to determine when infants and children with bronchiolitis should be taken to hospital by ambulance. The main reason to call an ambulance to take an infant or child to hospital, rather than to take the child by car is concern that the degree of airway obstruction may suddenly increase and the child’s condition may rapidly deteriorate. In the absence of evidence, and in consultation with the Victorian Metropolitan Ambulance Service, the GDG agreed to the following consensus recommendations: D An ambulance should be called for infants and children with severe or life threatening bronchiolitis. The person calling an ambulance should be prepared to answer a series of questions designed to enable the Metropolitan Ambulance Service to establish the level of urgency and send appropriate vehicles and staff. Questions may include: • • • • • • What is the exact location of the emergency? What is your call back phone number? What is the problem? (What exactly happened?) How old is the child? Is the child conscious? Is the child breathing? Further questions may be necessary. Non-pharmacological Management 37 Southern Health Clinical Practice Guideline for the Management of Bronchiolitis in Infants and Children 4.9.3 Emergency Department D If a general practitioner is not available, infants and children with moderate bronchiolitis should be taken to a hospital emergency department. D All infants or children with severe or life-threatening bronchiolitis should be sent by ambulance to an emergency department. Most infants and children with bronchiolitis will have mild or moderate bronchiolitis and will be observed in the emergency department and then sent home. A small number of infants or children with bronchiolitis may require a short hospital admission. 4.9.4 Intensive Care Unit Infants or children with life-threatening bronchiolitis, should be managed in conjunction with staff from the Intensive Care Unit. The Intensive Care Unit should also be consulted in the management of infants and children with severe bronchiolitis who require ongoing oxygen therapy at levels above 40%. D All infants or children with life-threatening bronchiolitis or severe bronchiolitis requiring ongoing oxygen therapy at levels above 40%, should be managed in conjunction with staff from the Intensive Care Unit. 4.9.5 Discharge Criteria There is no evidence on which to make a recommendation as to the appropriate discharge criteria for infants or children who present to hospital with bronchiolitis. In the absence of evidence the GDG made the following consensus recommendations: D Infants and children with bronchiolitis can be discharged from the Intensive Care Unit to the paediatric ward when they have no signs of life-threatening bronchiolitis. D Infants and children with bronchiolitis can be discharged from hospital when they have no signs of moderate bronchiolitis requiring oxygen or fluid therapy; severe or life-threatening bronchiolitis. 4.9.6 Follow-up There is no evidence on which to make a recommendation as to the appropriate follow-up or referral procedures for infants or children with bronchiolitis. The GDG agreed that it was essential that the child’s GP be notified promptly of the child’s presentation to hospital. They also noted the importance of patient confidentiality and emphasised that every care should be taken to ensure that communication with the GP is as secure as possible. Non-pharmacological Management 38 Southern Health Clinical Practice Guideline for the Management of Bronchiolitis in Infants and Children On discharge from hospital the family should be given information on when to seek further medical attention and alerted to the importance of communication between the hospital and GP. D A letter should be sent by fax, mail or email to the GP (and any relevant specialists) of any infant or child presenting with bronchiolitis to hospital. D On discharge the family should be given information on when to seek further medical attention, and a copy of the discharge summary. The GDG agreed that infants and children with bronchiolitis should usually be seen by a doctor (preferably their GP) to review their progress, 2 days after discharge from hospital or 2 days after their initial presentation, if not admitted to hospital. Infants and children who are at higher risk of severe bronchiolitis, such as those who are <3 months old, were born at <36 weeks gestation, or who have underlying cardiorespiratory disease, may require more rapid review. D Infants and children with bronchiolitis should be reviewed by their GP 2 days after initial GP or ED presentation or discharge from hospital, or at any time if their clinical condition deteriorates. 4.10 Observations There is little evidence on which to base recommendations for ongoing observations for assessment of severity of disease in infants and children with bronchiolitis. 4.10.1 Clinical signs The GDG agreed that the most important observations for infants and children with bronchiolitis are: • Accessory muscle use, nasal flare, grunting, tracheal tug or chest wall retraction • Respiratory rate • Oxygen saturation • Heart rate (see table 2 on page 17) 4.10.2 Frequency of observations There is no evidence on which to make a recommendation about the frequency of observations in infants and children with bronchiolitis. In the absence of evidence the GDG agreed to the following recommendations: 4.10.3 Mild to moderate bronchiolitis In infants and children with mild-moderate bronchiolitis, nursing observations using the clinical signs outlined in section 3.4.1 should be undertaken regularly while the infant or child is in hospital. Non-pharmacological Management 39 Southern Health Clinical Practice Guideline for the Management of Bronchiolitis in Infants and Children D For infants and children with mild bronchiolitis, assess the following clinical signs at least once every four hours, taking care not to distress the infant or child: • Accessory muscle use, tracheal tug or chest wall retraction • Respiratory rate • Oxygen saturation • Heart rate. D For infants and children with moderate bronchiolitis, assess the following clinical signs at least once every two hours, taking care not to distress the infant or child: • Accessory muscle use, tracheal tug or chest wall retraction • Respiratory rate • Oxygen saturation • Heart rate. 4.10.4 Severe or life-threatening bronchiolitis In infants and children with severe or life-threatening bronchiolitis close medical assessment is necessary and nursing observations should be more frequent. D Infants and children with life-threatening or severe bronchiolitis are likely to require continuous monitoring and constant supervision. Assess the following clinical signs at least once every 30 minutes and more frequently if the infant or child’s condition is deteriorating: • Accessory muscle use, tracheal tug or chest wall retraction • Respiratory rate • Oxygen saturation • Heart rate. 4.11 Hospital Infection Control Most of the little evidence which is available about infection control in infants and children with bronchiolitis refers to RSV positive infants and children only. In RSV positive infants and children the Southern Health Infection Control and Epidemiology Manual recommends that Standard Precautions, along with Droplet and Contact Precautions be employed. The most recent edition of this publication is available on the Southern Health Intranet. As a result of the fact that RSV testing is not recommended for most infants and children with bronchiolitis, usually it will not be clear whether infants and children with bronchiolitis at Southern Health hospitals are infected with RSV or another organism. Regardless of the organism causing bronchiolitis, it is sensible to take precautions to ensure it is not spread. Non-pharmacological Management 40 Southern Health Clinical Practice Guideline for the Management of Bronchiolitis in Infants and Children In the absence of evidence, in light of the existing Southern Health Infection Control Guidelines and in discussion with the Southern Health Infection Control & Epidemiology Unit, the GDG agreed that: D Infants and children with bronchiolitis at Southern Health, regardless of RSV status, should be managed according to the Southern Health Infection Control Guidelines following Standard, Droplet and Contact Precautions. The Southern Health Infection Control Guidelines for RSV infection suggest that where possible RSV positive infants and children should be accommodated in single rooms, and that where this is not possible infants and children can be managed in shared rooms with other infants and children infected with the same micro-organism. As discussed above, the infecting micro-organism will not be identified for most infants and children with bronchiolitis. The GDG and Southern Health Infection Control & Epidemiology Unit noted that most infants and children with bronchiolitis will be accommodated in cots which restrict the movement of the infant or child and thus, to some extent, the transmission of the infecting organism. Keeping infants and children with bronchiolitis separated by at least two metres (a radius of one meter around each infant or child) will further reduce the possibility of transmission of micro-organisms by contact or droplets. In the absence of evidence, in line with the existing Southern Health Infection Control Guidelines and in discussion with the Southern Health Infection Control & Epidemiology Unit, the GDG agreed that: D Infants and children with bronchiolitis can be accommodated in shared rooms where single rooms are not available. D Where infants and children with bronchiolitis are accommodated in shared rooms, infants and children and any associated equipment or toys should be separated by at least two metres (a radius of one meter around each infant or child). 9 Take special care in infants and children with bronchiolitis who have underlying chronic illnesses which might make them more vulnerable to infection. Non-pharmacological Management 41 Southern Health Clinical Practice Guideline for the Management of Bronchiolitis in Infants and Children 5. Patient Education and Self-Management Patient Education and Self-Management 42 Southern Health Clinical Practice Guideline for the Management of Bronchiolitis in Infants and Children Patient Education and Self-Management 43 Southern Health Clinical Practice Guideline for the Management of Bronchiolitis in Infants and Children 6. Outcome and Audit There are many different frameworks for developing outcome and audit measures. For the purpose of evaluating the implementation of this guideline we defined two types of measures; process and outcome. Process measures assess the success of the implementation process and the degree of implementation achieved. Outcome measures assess whether the implementation has improved clinical practice and patient outcomes. 6.1 Process measures 6.1.1 Implementation process • Proportion of target groups that received the interventions outlined in the implementation and dissemination plan. This information will be collected by attendance sheets and other similar documentation. 6.1.2 Degree of implementation • Proportion of eligible patients on clinical paths and proportion of clinical paths completed correctly. This information will be collected by audit of patient records 6.2 Outcome measures 6.2.1 Clinical practice A survey was sent to members of the GDG and clinicians involved in paediatric services at Southern Health which asked them to reviewed the recommendations for clinical management of infants and children with bronchiolitis from this guideline and to identify which of the recommendations would require a change from existing clinical practice. Outcome measures were then chosen to enable assessment of whether clinical practice had changed to reflect the recommendations of the guideline in appropriate clinical areas. These measures are not an exhaustive list but represent those areas of clinical practice change agreed by the GDG to be most relevant and important. • Proportion of infants and children with bronchiolitis o receiving oxygen therapy in whom oxygen saturations are maintained between 92 and 95% o who receive virological testing o receiving the recommended fluids o receiving fluids by oral, nasogastric, intravenous routes. Outcome and Audit 44 Southern Health Clinical Practice Guideline for the Management of Bronchiolitis in Infants and Children 6.2.2 Patient outcomes To develop a set of outcome measures we reviewed the original aims of the guideline development. These aims included reducing emergency department presentations, reducing hospital admissions, reducing length of stay in hospital and reducing the representation rate In light of this, the GDG agreed that the following measures should be assessed for infants and children with bronchiolitis, prior to and post implementation of the guideline through a clinical path: • Number of presentations to ED, number of admissions and number of representations to ED within seven days • Proportion of presentations to ED admitted and proportion of presentations to ED representing within seven days • Length of stay Outcome and Audit 45 Southern Health Clinical Practice Guideline for the Management of Bronchiolitis in Infants and Children 7. Dissemination and Implementation of the Guideline Inform Educate Motivate Raise awareness of the guideline and clinical path through multiple strategies that will inform a wide range of staff Provide information at a variety of forums to outline how and why the guideline and clinical path were developed. Provide hands-on training for staff to be up skilled in their knowledge of the management of bronchiolitis and to provide education to patients and their families • Meeting with the Children’s Program Management about guideline and clinical path • Discussion at SMS meeting of guideline and clinical path • Discussion with those responsible for physician training about guideline and clinical path • HMO education re guideline and clinical path • Meeting with NUMs, nurse educators, nurse facilitators & site DON about guideline, clinical path & implementation strategy • Nurse facilitators to provide education on unit with support from implementation group • Meet with paediatric Allied Health about guideline and clinical path Work with staff to provide ongoing support and a feedback mechanism throughout the implementation of the guideline and clinical path Who Program Management Medical • Put notices in SMS pigeon holes about the availability of guideline and implementation of clinical path Nursing Allied Health Ward Clerks General Practitioners Community Health General • One-on-one meetings with key clinicians and opinion leaders to encourage them to motivate others • Involve Nurse Educators and Clinical Nurse Specialists in ongoing education • One-on-one meetings with NUMs to encourage them to motivate their staff • Work with Allied Health representatives to motivate staff and involve them in implementation • Meet with Ward Clerks to • Work with the Ward Clerks explain clinical path and how to keep them informed and it is used motivated throughout the implementation • An implementation plan to address the specific needs of General Practitioners is being developed by the GP Liaison Officer as a separate strategy to the acute implementation plan • Strategies to inform pharmacists and other relevant community health services are currently being developed • Place guideline on Southern • Include as part of • Regular meetings with Health internet and intranet orientation for new staff different groups to discuss • Email all relevant staff about • ED education sessions re benefits/challenges of the availability of the guideline and clinical path guideline and clinical path guideline • Provide “hands on” training • Regular updates about • Distribute copies of guideline for medical, nursing and progress in implementation to key staff and place in Allied Health staff and resulting improvements EDs, wards, staff rooms • Use GDG members to • Use posters in departments motivate staff to use to inform and remind staff of documents guidelines etc • Put notice in Purple Peril about availability of guideline • Put notice on payslips about availability of the guideline Dissemination and Implementation of the Guideline 46 Southern Health Clinical Practice Guideline for the Management of Bronchiolitis in Infants and Children 8. Guideline Development Process 8.1 Southern Health Bronchiolitis Guideline Development The development of these Guidelines was undertaken by the Health for Kids in the South East Bronchiolitis Guideline Development Group at Southern Health. Melinda Wilson (Clinical Scholar — Health for Kids in the South East) and Fiona Wilkinson (Senior Project Officer — Health for Kids in the South East) co-ordinated the process and Tari Turner (Senior Project Officer — Health for Kids in the South East) was responsible for identifying and appraising the evidence, and drafting the guidelines. Members of the Guideline Development Group represented all clinical areas at Southern Health relevant to the care of infants and children with bronchiolitis, as well as consumer representation. Members of the group were: Name Role Merrin Bamert Shirley Burke Rowena Clayton Simon Costello Graeme Downe Peter Francis Peter Fritz Claire Harris Natalie Hood Ilana Laser Angela Luangrath David Meldrum Anna Murphy Daniel O’Neill Mali Ranasinghe Junelle Rhodes Gina Ruwoldt Alia Sadiq Amanda Smith Jody Smith Priya Thangarajah Clinical Nurse Educator, Emergency Department, Monash Medical Centre Paediatric Clinical Nurse Educator Nurse, Emergency Department, Casey Hospital Paediatrician, Monash Medical Centre GP Liaison Officer Emergency Physician, Emergency Department, Monash Medical Centre Senior Medical Officer, Emergency Department, Dandenong Hospital Project Manager, Health for Kids in the South East Emergency Physician, Emergency Department, Monash Medical Centre Paediatric Resident, Monash Medical Centre Paediatric Resident, Monash Medical Centre Paediatrician, Emergency Department, Casey Hospital Paediatric Respiratory Fellow, Monash Medical Centre Clinical Nurse Specialist, Emergency Department, Casey Hospital Paediatric Nurse, Dandenong Hospital Consumer Nurse Unit Manager, 42North, Monash Medical Centre Consumer Paediatric Fellow, Monash Medical Centre Clinical Guidelines and Pathway Co-ordinator, Royal Children’s Hospital Melbourne Paediatric Nurse, 41North, Monash Medical Centre Declaration of Interest forms were completed by all members of the Guideline Development Group, no conflicts of interest were identified. Guideline Development Process 47 Southern Health Clinical Practice Guideline for the Management of Bronchiolitis in Infants and Children 8.1.2 Acknowledgements We thank the following people for their important contribution to the development of this guideline. Name Role Contribution Dr Trevor Kerr Unit Head, Southern Health, Microbiology Victorian Infectious Disease Reference Laboratory Southern Cross Pathology, Australia Nurse Consultant, Southern Health Infection Control and Epidemiology Unit Metropolitan Ambulance Service (MAS) Expert knowledge on RSV testing Expert knowledge on RSV testing Expert knowledge on RSV testing Advice on infection control measures Senior Scientists, Virus Identification Unit Laboratory Staff Judy Brett Emily England John Wheeler Consultation in regard to MAS protocols 8.2 Methodology This guideline was developed by a multidisciplinary guideline development group (GDG) which included representatives of all clinical areas involved in caring for infants and children with bronchiolitis and their parents. The membership of the group is outlined above in section 7.1. The development process followed is outlined in figure #. A broad search was undertaken to identify existing evidence-based guidelines for the management of bronchiolitis. The search included: • published literature (Medline, CINAHL, Embase), • websites referring to clinical guidelines (including www.guidelines.gov, www.rch.org.au, www.nhmrc.gov.au, http://www.leitlinien.de) • the internet. Several existing clinical practice guidelines for the management of bronchiolitis were identified. In most cases it was clear that these guidelines were consensus-based (not evidence-based) documents. Some guidelines appeared to be potentially evidence-based, in these cases the GDG attempted to contact the authors, or publishing institutions in order to determine the methodology used in the guideline development. No guidelines were identified which had been developed by a methodologically rigorous, evidence-based process. An Evidence Report/Technology Assessment “Management of Bronchiolitis in Infants and Children” published by the Agency for Healthcare Research and Quality (AHRQ) in January 2003 was identified and this report was a useful reference in the development of this guideline. In the absence of existing evidence-based guidelines for the management of infants and children with bronchiolitis, the GDG decided to develop a new guideline, following an evidence-based process. In consultation with their colleagues, the GDG developed a list of questions that a bronchiolitis management guideline should address. Guideline Development Process 48 Southern Health Clinical Practice Guideline for the Management of Bronchiolitis in Infants and Children Where these questions were addressed by the AHRQ Evidence Report, searches were taken to identify any more recent evidence, and the content of the report revised to be appropriate for the local context. Where a question was not addressed by the AHRQ Evidence Report, searches of published research evidence were then undertaken to identify evidence to answer the questions. Evidence identified to answer the clinical questions was appraised using a standard appraisal format (see section 7.4). Where evidence existed to answer clinical questions, evidence-based recommendations were made, with the level of the recommendation reflecting the quality and generalisability of the evidence available to answer the question. Where there was no, or very low quality, evidence to answer a clinical question, recommendations were made on the basis of the consensus of the GDG. Each chapter of the guideline was drafted by a member of the GDG with expertise in the identification and appraisal of research evidence, in consultation with the coordinators of the GDG process, and then revised and adapted in the light of feedback from GDG meetings. The development of the guideline also included consultation with the Melbourne Metropolitan Ambulance Service. The final document was circulated to key clinical leaders outside the GDG and members of the Southern Health Executive for endorsement. Guideline Development Process 49 Southern Health Clinical Practice Guideline for the Management of Bronchiolitis in Infants and Children Figure 1. Guideline Development Process 1. Define and scope the guideline Are there suitable existing evidence-based guidelines? yes Is adaptation for local situation required? no yes no 2. Convene a multidisciplinary guideline panel 3. Develop the clinical question(s) 4. Identify and appraise scientific evidence to answer questions Is there Level I-IV evidence in respect of each recommendation? yes 5a. Develop evidence-based recommendations or update existing recommendations no Is there consensus? no yes 5b. Develop consensusbased recommendations that indicate lack of clear evidence but acknowledge consensus 5c. Make brief non-consensus statement (state options and acknowledge uncertainty) 6. Write 3 guideline versions 7. Consultation & pilot testing 8. Disseminate and implement 9. Evaluate and revise Guideline Development Process 50 Southern Health Clinical Practice Guideline for the Management of Bronchiolitis in Infants and Children 8.3 Searches All searches to identify research evidence to answer clinical questions followed a standard process. Medline from 1966-present (Ovid) and CINAHL (Ovid) were searched on each occasion and The Cochrane Library was searched for all questions regarding management. Searches were restricted by language of publication (English) and to those publications reporting on studies in humans. A summary of the searches undertaken is provided below. Details of each search strategy are available on request. Duration of illness Search Term 1 2 3 Bronchiolitis terms Duration terms Combine 1 & 2 Abstracts reviewed Papers reviewed Papers used Chest x-rays Search Term 1 2 3 4 Bronchiolitis terms X-ray terms Combine 1 & 2 Limit to 2002-2005 Abstracts reviewed Papers reviewed Papers used Nasopharyngeal aspirates Search Term 1 2 3 4 Bronchiolitis terms NPA terms Combine 1 & 2 Limit to 2002-2005 Abstracts reviewed Papers reviewed Papers used Guideline Development Process Medline 1966present 1652 452877 182 188 2 2 CINAHL 1982 current 182 22304 32 Medline 1966present 1652 625630 116 25 27 1 0 CINAHL 1982 current 182 24028 11 6 Medline 1966present 1652 3206 95 28 28 1 1 CINAHL 1982 current 182 33 3 2 26/09/05 The Cochrane Library Not applicable 27/09/05 The Cochrane Library Not applicable 28/09/05 The Cochrane Library Not applicable 51 Southern Health Clinical Practice Guideline for the Management of Bronchiolitis in Infants and Children Blood and/or urine culture Search Term 1 2 3 Bronchiolitis terms Blood or urine culture terms Combine 1 & 2 Abstracts reviewed Papers reviewed Papers used Blood gas analysis Search Term 1 2 3 Bronchiolitis terms Blood gas analysis terms Combine 1 & 2 Abstracts reviewed Papers reviewed Papers used Assessment of severity Search Term 1 2 3 Bronchiolitis terms Blood gas analysis terms Combine 1 & 2 Abstracts reviewed Papers reviewed Papers used Isolation Search Term 1 2 3 Bronchiolitis terms Isolation terms Combine 1 & 2 Abstracts reviewed Papers reviewed Papers used Adrenaline Search Term 1 2 3 Bronchiolitis terms Adrenaline terms Combine 1 & 2 Restricted to 2002-2005 Abstracts reviewed Papers reviewed Papers used Guideline Development Process Medline 1966present 1652 179835 55 24 13 12 CINAHL 1982 current 182 6217 4 Medline 1966present 1653 27871 32 23 0 0 CINAHL 1982 current 182 2765 6 Medline 1966present 1653 692545 300 300 16 7 CINAHL 1982 current 182 47373 43 Medline 1966present 1652 670744 124 CINAHL 1982 current 182 8432 4 28/09/05 The Cochrane Library Not applicable 28/09/05 The Cochrane Library Not applicable 30/09/05 The Cochrane Library Not applicable 27/09/05 The Cochrane Library 230 6932 16 0 Medline 1966present 1669 53996 59 33 33 12 1 CINAHL 1982 current 193 1101 19 15/11/05 The Cochrane Library 233 4486 30 52 Southern Health Clinical Practice Guideline for the Management of Bronchiolitis in Infants and Children Bronchodilators Search Term 1 2 3 Bronchiolitis terms Bronchodilator terms Combine 1 & 2, restrict to 20022005 Abstracts reviewed Papers reviewed Papers used Ipratropium bromide Search Term 1 2 3 Bronchiolitis terms Ipratropium bromide terms Combine 1 & 2, restrict to 20022005 Abstracts reviewed Papers reviewed Papers used Antibiotics Search Term 1 2 3 Bronchiolitis terms Antibiotic terms Combine 1 & 2, restrict to 20022005 Abstracts reviewed Papers reviewed Papers used Corticosteroids Search Term 1 2 3 Bronchiolitis terms Steroid terms Combine 1 & 2, restrict to 20022005 Abstracts reviewed Papers reviewed Papers used Ribavirin Search Term 1 2 3 Bronchiolitis terms Ribavirin terms Combine 1 & 2, restrict to 20022005 Abstracts reviewed Papers reviewed Papers used Guideline Development Process Medline 1966present 1669 168601 76 CINAHL 1982 current 193 3214 34 16/11/05 The Cochrane Library 233 12853 34 40 10 2 Medline 1966present 1669 1675 9 CINAHL 1982 current 193 154 2 17/11/05 The Cochrane Library 233 1052 11 5 2 1 Medline 1966present 1669 404413 31 CINAHL 1982 current 193 9413 7 17/11/05 The Cochrane Library 233 11421 12 10 2 1 Medline 1966present 1670 300523 43 CINAHL 1982 current 193 8343 16 18/11/05 The Cochrane Library 233 23694 33 25 8 4 Medline 1966present 1670 4412 22 CINAHL 1982 current 193 343 5 21/11/05 The Cochrane Library 233 935 7 10 4 1 53 Southern Health Clinical Practice Guideline for the Management of Bronchiolitis in Infants and Children Immunoglobulin Search Term 1 2 3 Bronchiolitis terms Immunoglobulin terms Combine 1 & 2, restrict to 20022005 Abstracts reviewed Papers reviewed Papers used Analgesics and Antipyretics Search Term 1 2 3 Bronchiolitis terms Analgesic and Antipyretic terms Combine 1 & 2 Abstracts reviewed Papers reviewed Papers used Cough mixture and decongestants Search Term 1 2 3 Bronchiolitis terms Cough mixture / decongestant terms Combine 1 & 2 Abstracts reviewed Papers reviewed Papers used Oxygen Search Term 1 2 3 Bronchiolitis terms Oxygen terms Combine 1 & 2 Abstracts reviewed Papers reviewed Papers used Hydration Search Term 1 2 3 Bronchiolitis terms Hydration terms Combine 1 & 2 Abstracts reviewed Papers reviewed Papers used Guideline Development Process Medline 1966present 1670 227661 3 CINAHL 1982 current 193 1776 2 21/11/05 The Cochrane Library 233 4659 0 3 1 1 Medline 1966present 1670 217950 6 1 1 0 CINAHL 1982 current 193 1286 0 Medline 1966present 1670 44374 CINAHL 1982 current 193 1249 3 3 1 0 0 Medline 1966present 1720 269130 208 35 10 0 CINAHL 1982 current 197 9882 37 Medline 1966present 1720 448425 108 22 9 0 CINAHL 1982 current 197 18661 24 21/11/05 The Cochrane Library 233 17760 8 24/11/05 The Cochrane Library 233 3207 1 20/01/06 The Cochrane Library 234 14377 78 23/01/06 The Cochrane Library 234 46484 43 54 Southern Health Clinical Practice Guideline for the Management of Bronchiolitis in Infants and Children Chest Physiotherapy Search Term 1 2 3 Bronchiolitis terms Chest Physiotherapy terms Combine 1 & 2 Abstracts reviewed Papers reviewed Papers used Saline drops Search Term 1 2 3 Bronchiolitis terms Drop terms Combine 1 & 2 Abstracts reviewed Papers reviewed Papers used Suctioning Search Term 1 2 3 Bronchiolitis terms Suctioning terms Combine 1 & 2 Abstracts reviewed Papers reviewed Papers used Apnoea Search Term 1 2 3 Bronchiolitis terms Apnoea terms Combine 1 & 2 Abstracts reviewed Papers reviewed Papers used Position Search Term 1 2 3 Bronchiolitis terms Position terms Combine 1 & 2 Abstracts reviewed Papers reviewed Papers used Guideline Development Process Medline 1966present 1720 133474 24 1 1 1 CINAHL 1982 current 197 25546 14 Medline 1966present 1720 68589 7 1 0 0 CINAHL 1982 current 197 3785 2 Medline 1966present 1720 14463 12 0 0 0 CINAHL 1982 current 197 1318 5 Medline 1966present 1725 21833 46 47 11 0 CINAHL 1982 current 197 2231 6 Medline 1966present 1731 401156 13 1 1 1 CINAHL 1982 current 197 21721 4 24/01/06 The Cochrane Library 234 5992 3 24/01/06 The Cochrane Library 234 11607 25 24/01/06 The Cochrane Library 234 1229 6 24/01/06 The Cochrane Library 234 1789 4 31/01/06 The Cochrane Library 236 12231 10 55 Southern Health Clinical Practice Guideline for the Management of Bronchiolitis in Infants and Children Oximetry Search Term 1 2 3 Bronchiolitis terms Oximetry terms Combine 1 & 2 Abstracts reviewed Papers reviewed Papers used Guideline Development Process Medline 1966present 1735 8872 32 4 2 2 CINAHL 1982 current 201 1414 9 15/02/06 The Cochrane Library 238 928 19 56 Southern Health Clinical Practice Guideline for the Management of Bronchiolitis in Infants and Children 8.4 Critical Appraisal of Identified Research 8.4.1 Nebulised adrenaline Study Selection Criteria Patient Infants or children with bronchiolitis Intervention Nebulised adrenaline Hartling et al Sys Rev 8 studies (365 patients) Placebo Outcomes Study Type Any Language English Characteristics of included studies: Study Study Type N(total) Patients 144 Comparison Publication Date Infants and young children up to 24 months of age with bronchiolitis Any Any Number of included studies: 1 SR Intervention Comparison Outcomes Adrenaline Placebo Clinical score, oxygen saturation, admission to hospital, LOS, RR, HR, pulmonary function tests Hartling et al 144 Yes Yes Yes Some Statistically Yes Strengths and limitations of included studies discussed Summary of main results presented Homogeneity between studies assessed Validity of included trials appraised Explicit and comprehensive search strategy Study Specified inclusion/ exclusion criteria Focused research question Quality of included studies: Little Comments • Includes adrenaline vs salbutamol (not discussed here) • Appraisal of papers was blind to authors and institutes • Minimal discussion of appraisal of papers and homogeneity Results of included studies: • 5 studies investigated inpatient use of adrenaline. In these studies there was no difference between the groups in change in clinical score at 30mins, change in oxygen saturation at 30mins or 60 mins, HR at 30 or 60 mins, RR at 30 or 60 mins, LOS, or pallor. Infants in the adrenaline group had a slightly greater reduction in clinical score at 30 mins SMD -0.52(95%CI -1.00, -0.03) • 3 studies investigated outpatient use of adrenaline. In these studies there was no difference between the groups in admission rates, change in clinical score at 30mins, change in oxygen saturation at 30mins or 60 mins or HR at 30mins. Statistically significant differences were found in change in clinical score at 60 minutes (SMD -0.81; 95% CI -1.56,-0.07), change in oxygen saturation at 30 minutes (WMD 2.79; 95% CI 1.50,4.08), respiratory rate at 30 minutes (WMD -4.54; 95% CI -8.89,-0.19), Guideline Development Process 57 Southern Health Clinical Practice Guideline for the Management of Bronchiolitis in Infants and Children 8.4.2 β2agonist bronchodilators Study Selection Criteria Patient Infants or children with bronchiolitis Comparison Placebo or control Intervention β2agonist bronchodilators Outcomes Any Study Type Any Language English Characteristics of included studies: Study Study Type N(total) Patients King et al145 Sys Rev 1036 (12 studies) Publication Date Infants and children with bronchiolitis Any Number of included studies: 1 Sys Rev Intervention Comparison Outcomes Beta2agonist bronchodilators Placebo or no treatment Hospitalisation, LOS, clinical score, HR, RR< oxygen saturation King et al 145 Yes Yes Yes Yes Unclear Yes Strengths and limitations of included studies discussed Summary of main results presented Homogeneity between studies assessed Validity of included trials appraised Explicit and comprehensive search strategy Study Specified inclusion/ exclusion criteria Focused research question Quality of included studies: Minimal Results of included studies: Comments • Study by Patel 2002 (their reference 21) is missing from Table 4, but present in Table 3. Results of this study not included (though consistent) in β2agonist bronchodilators discussion. • 12 studies compared β2agonist bronchodilator to placebo. • No differences were found between groups in any of the 7 studies reporting admission or LOS outcomes. • 9 studies found no differences between groups on any measured outcomes. • 2 studies reported short term improvements in clinical score; at 30mins and 60mins in one study and at 30mins only in the 2nd study. • 1 study reported lower mean decrease in RR in placebo group. • 1 study reported worse oxygenation in treatment group. • Non-significant increased tachycardia and/or decreased oxygenation was reported in 5 studies Guideline Development Process 58 Southern Health Clinical Practice Guideline for the Management of Bronchiolitis in Infants and Children 8.4.3 Ipratropium bromide Study Selection Criteria Patient Infants or children with bronchiolitis Comparison Placebo or control Intervention Ipratropium bromide Outcomes Any Study Type Any Language English Characteristics of included studies: Study Study Type N(total) Patients King et al145 Sys Rev 240 (3 studies) Publication Date Infants and children with bronchiolitis Any Number of included studies: 1 Sys Rev Intervention Comparison Outcomes Ipratropium bromide Placebo or no treatment Hospitalisation, LOS, clinical score, HR, RR< oxygen saturation King et al 145 Yes Yes Yes Yes Results of included studies: Unclear Yes Strengths and limitations of included studies discussed Summary of main results presented Homogeneity between studies assessed Validity of included trials appraised Explicit and comprehensive search strategy Study Specified inclusion/ exclusion criteria Focused research question Quality of included studies: Minimal Comments • Studies described in Table 4 as they also have arms testing β2agonist bronchodilators • 3 studies compared ipratropium bromide to placebo. • No differences were found between ipratropium bromide and placebo groups in LOS or clinical outcomes. • One trial showed that ipratropium bromide + salbutamol was better than either agent alone, but the combination was not significantly more effective than placebo. Guideline Development Process 59 Southern Health Clinical Practice Guideline for the Management of Bronchiolitis in Infants and Children 8.4.4 Antibiotics Appraisal Table from AHRQ HTA118 Study Characteristics Author: Friis et al, 198449 Setting: Denmark, Inpatient Stated Objective of Study To assess the effect of routine administration of antibiotics in the treatment of viral pneumonia and bronchiolitis Follow-up: Acute, short term, 3 wks Study design RCT - No placebo Length of enrolment: Dec 1979 to Nov 1982 Masking: Open label Intervention Intervention Group A (n = 34) Antibiotics: • If < 2 yrs, Ampicillin PO 100mg/kg/day TID x 6 days • If > 2 yrs, V Penicillin 300000 IU TID x 6 days • If > 2 yrs with penicillin allergy, erythromycin 30 - 50mg/kg/day TID x 6 days • Treatment changed if strains were resistant (No details reported) Group B (n = 27) Control No therapy, 7 patients given antibiotics when they developed cyanosis, or bacterial complications, or fever lasting more than 4 days without viral infection diagnosed by IFA antibody test. Other treatment NR Guideline Development Process Inclusion/Exclusion Criteria Demographic Characteristics and Cormorbidities Inclusion criteria • Children with pneumonia admitted to pediatric wards • Ill for less than one wk • No antibiotics before • hospital admission Number: 136 eligible of which 61 had RSV (evidence table limited to RSV Subgroup) Exclusion criteria • Chronic pulmonary or cardiac disease • Mental retardation • Oncologic diseases • Severe breathing difficulties or cyanosis Oxygen treatment or artificial ventilation • Suspected septicemia Median age at enrollment in mos : Antibiotics: 18 Control: 17.5 Mean gestational age NR Sex: Antibiotics: 65% male (47/72) Control: 67% male (44/66) Comorbidities: None Outcome Primary outcome • Mean duration of hospitalization in days ± SE (antibiotics vs. control for RSV subgroup) 5.2 ± 0.3 vs. 5.4 ± 0.4 • ‘Pulmonarily healthy’ on day 3 (antibiotics vs. control for RSV subgroup) 11 (32.4%) vs. 9 (33.3%) • ‘Pulmonarily healthy’ at discharge (antibiotics vs. control for RSV subgroup) 25 (73.5%) vs. 24 (88.9%) • ‘Pulmonarily healthy’ after 3 wks (antibiotics vs. control for RSV subgroup) 27 (79.4%) vs. 20 (74.1%) Secondary outcomes • Respiratory rate per mins measured at days 1, 2, 3 and discharge • Radiological findings on admission and after 3 wks Quality Significant differences between study groups • No, P value NR • No, P value NR • No, P value NR Quality: Fair Significant differences at baseline: NR Other comments • Neither patients nor investigators were blinded • No, P value NR • No, P value NR • No, P value NR Adverse events: Fever, respiratory distress, coughing, otalgia, skin eruptions, GI symptoms, medical attention, antibiotics after day 10 for all patients, details NR for bronchiolitis group 60 Southern Health Clinical Practice Guideline for the Management of Bronchiolitis in Infants and Children 8.4.5 Corticosteroids Study Selection Criteria Patient Infants or children with bronchiolitis Comparison Placebo or control Intervention Corticosteroids Outcomes Any Study Type Any Language English Characteristics of included studies: Study Study Type N(total) Patients Publication Date Any Number of included studies: 2 Sys Revs, 2RCTs Intervention Comparison Outcomes Patel et al146 Sys Rev 1198 (13 studies) Infants and children with acute viral bronchiolitis – recurrent wheezers and ICU admissions excluded Oral, intravenous or intramuscular corticosteroids Placebo or control Hospitalisation, LOS, clinical score, HR, RR< oxygen saturation Davison et al147 Sys Rev 137 (3 studies) Mechanically ventilated infants and children with bronchiolitis Oral, intravenous or intramuscular corticosteroids Placebo or control Duration of mechanical ventilation, LOS Patel et al 146 Yes Strengths and limitations of included studies discussed Summary of main results presented Homogeneity between studies assessed Validity of included trials appraised Explicit and comprehensive search strategy Study Specified inclusion/ exclusion criteria Focused research question Quality of included studies: Comments Yes Yes Yes Yes Yes Some • Study results were significantly heterogeneous Davison et al Yes Yes Results of included studies: Yes Yes Yes Yes Some • Study treatments were of varying duration and dose 147 Patel et al146 found • a non-significant a decrease in LOS in patients treated with corticosteroids of 0.38 days (95% CI -0.81 to 0.05). • In the 3 studies of 100% RSV positive infants and young children where LOS was reported, the meta-analysis gave a WMD of -0.67 (95% CI -1.11 to 0.24) LOS for treated infants and young children in this group compared to placebo. • No statistically significant differences in clinical scores, respiratory rates or oxygen saturation were found between treatment groups in an of the studies. • 3 trials reported hospital admission rates. In 2 of these trials admission rates were non-significantly, but substantially higher in the treatment group, and in the third trial the admission rate was significantly higher in the placebo group. Meta-analysis found no difference between groups. Davison et al146 found no significant differences in duration of mechanical ventilation or LOS between groups. Guideline Development Process 61 Southern Health Clinical Practice Guideline for the Management of Bronchiolitis in Infants and Children 8.4.5 Corticosteroids continued – Randomised Controlled Trials Characteristics of included studies: Study Study Type N(total) Zhang et al 148 Kuyucu et al149 Patients Intervention Comparison Outcomes RCT 52 Infants ≤12months admitted with bronchiolitis 1mg/kg prednisolone for 5 days No steroids Prevalence of wheezing at 1, 3, 6 & 12 months, LOS, duration of O2, RCT 69 Infants 2-21 months in ED with acute bronchiolitis with RDAI≥4 Adrenaline and dexamethasone, or salbutamol and dexamethasone Adrenaline and placebo, or salbutamol and placebo RR, HR, RDAI at admission, 30, 60, 90 and 120mins Not described Not described Some See note Some 12 months 2 months Proportion lost to follow up Yes Duration of follow-up Blinding – patients/ investigators/ assessors Yes Inclusion of all subjects in analysis Yes Yes Objective & independent assessment of outcomes Kuyucu et al149 Yes Groups similar at baseline Zhang et al 148 Concealment of allocation Study Adequate method of randomisation Specified inclusion/ exclusion criteria Quality of included studies: 2 (8%) in steroid group Mostly Yes 42-3% in placebo 12% & 4% in treated Yes Comments • Investigators but not patients or families were blind • Parents recorded days of wheeze, but also tested at clinic No • Baseline characteristics only given for patients who completed the trial. Large proportion of data missing. • Parents and investigators blind, ED nurse prepared solutions Results of included studies: • Zhang et al148 found no differences in LOS or duration of O2 therapy between groups. Likewise there was no difference in rates of wheezing at 1, 3, 6 or 12 months post discharge. • Substantial proportion of placebo groups lost to follow-up in Kuyucu et al149 study makes interpretation of results difficult. No patients in any groups were admitted which suggests initial severity was low. No differences were found in retreatment rates. 5th days RDAI scores were lower in dexamethasone groups than placebo groups, however there were no differences in other outcomes so this may be an artefact, or related to high loss to follow-up Guideline Development Process 62 Southern Health Clinical Practice Guideline for the Management of Bronchiolitis in Infants and Children 8.4.6 Ribavirin Study Selection Criteria Patient Infants or children with bronchiolitis Comparison Placebo or control Intervention Ribavirin Outcomes Any Study Type Any Language English Characteristics of included studies: Study Study Type N(total) Patients King et al145 Sys Rev 320 (10 studies) Publication Date Infants and children with bronchiolitis Any Number of included studies: 1 Sys Rev Intervention Comparison Outcomes Ribavirin Placebo or no treatment Hospitalisation, LOS, duration of ventilation clinical score, HR, RR< oxygen requirement 145 King et al Yes Yes Results of included studies: Yes Yes Unclear Yes Strengths and limitations of included studies discussed Summary of main results presented Homogeneity between studies assessed Validity of included trials appraised Explicit and comprehensive search strategy Study Specified inclusion/ exclusion criteria Focused research question Quality of included studies: Minimal Comments • • Guideline Development Process 63 Southern Health Clinical Practice Guideline for the Management of Bronchiolitis in Infants and Children 8.4.7 Immunoglobulin Appraisal Table from AHRQ HTA118 Study Characteristics Stated Objective of Study Author: Rodriguez et al., 199725 To determine the safety and efficacy of RSVIG in the treatment of previously healthy children hospitalized with RSV infection Setting: United States, Inpatient at baseline, telephone follow-up Follow-up: • Acute , Short term -Monthly telephone calls • Long-term at 1 yr after intervention Study design: RCT-P Length of enrolment: 4 RSV seasons (yrs not stated) Masking: Double-blind Inclusion/Exclusion Criteria Inclusion criteria Number: 101 eligible, 98 completed study specimens positive for RSV • Acute lower respiratory symptoms of less than 4 days duration • Respiratory score of = 2.5 Exclusion criteria • Known or suspected cardiopulmonary disease • Premature birth with GA <32 wks • Immunodeficiency disease (including HIV infection) • Known serum IgA deficiency • Renal failure • Previous reaction to blood products • Receipt of blood or blood products in the preceding 60 days • Established diagnosis of reactive airway disease • Apnea without evidence of LRI on presentation • Inability to establish an intravenous line after 4 attempts • Admitted for Ribavirin therapy Sex: RSVIG: 48% male (22/46) Placebo 50% male (26/52) • Previously healthy ≤2 yrs of age • Hospitalized with bronchiolitis and/or pneumonia with nasal wash Intervention Intervention Group A (n = 46) RSVIG 30ml/kg (1500 mg/kg) IV infusion x 1 dose Group B (n = 52) Placebo IV Albumin 0.5%, same volume as intervention Other treatment Ribavirin therapy, IV fluids, nebulization treatments, steroids or antibiotics, supplemental oxygen, mechanical ventilation Guideline Development Process Demographic Characteristics and Cormorbidities Mean age at enrollment (yr.± SD) RSVIG: 0.20 ± 0.03 Placebo: 0.19 ± 0.03 Mean gestational age (wk.± SD) RSVIG: 38.0 ± 0.4 Placebo: 38.2 ± 0.4 Comorbidities: Patients on ventilators: RSVIG: 12/46 (26%) Placebo: 19/52 (37%) Outcome Primary outcome • Mean duration of hospitalization in days ± SE (RSVIG vs. Placebo) 4.58 ± 0.4 vs. 5.52 ± 0.69 • Mean duration of stay in ICU in days ± SE (RSVIG vs. placebo) 3.92 ± 0.58 (n = 25) vs. 6.60 ± 1.31 (n = 33) Quality Significant differences between study groups • No (P = 0.24) • No (P = 0.06) Secondary outcomes • • • • • • • • Duration of mechanical ventilation Duration of oxygen therapy Use of ribavirin Supplemental oxygen RSV neutralizing antibody Proportion of cultures for RSV Hospitalization of LRI in subsequent season Hospitalization of RSV LRI in subsequent season Subgroup analysis • Severity of illness • No (P = 0.45) • No • No • No • No • No • NR • NR • P values not Quality Good Significant differences at baseline • RSVIG grp more likely to have = 85% study entry O2 saturation level (46% vs. 29%, P = 0.07) • Placebo grp more likely to need ICU care and mechanical ventilation (Pvalue NR) Other comments • If pt received 25% of infusion, was eligible for adverse outcomes reporting 64 Southern Health Clinical Practice Guideline for the Management of Bronchiolitis in Infants and Children • -Among subgroup with more severe disease (respiratory scores = 3.0), lower duration of hospitalization in RSVIG grp than placebo ICU stay at entry -Lower duration of hospitalization in RSVIG grp than placebo provided, n too small and if 75% of infusion then also for all other outcomes • P values not provided, n too small Adverse events • Benign nocturnal myoclonus not related to RSVIG (1 RSVIG pt) • Cardiopulmonary findings (6 RSVIG pts, 8 placebo pts) Study Characteristics Author: Rodriguez et al., 199741 Year: 1997 Setting: United States, Multi-center, Inpatient Stated Objective of Study To evaluate the efficacy of intravenous RSVIG to treat severe RSV in high risk infants Follow-up: • Acute • Short term -Monthly telephone calls • Long-term at 1 yr after intervention Intervention Guideline Development Process Number 107 enrolled, 102 received adequate dose, 96 at 8 wk followup, 98 at 1 yr follow-up High-risk criteria definitions: − severe BPD − other serious chronic lung disease − congenital heart disease − preterm infants <6 months old and <32 wks gestation Sex RSVIG: 45% male (23/51) Placebo: 57% male (29/51) Exclusion criteria Masking: Double-blind Primary outcome Demographic Characteristics and Cormorbidities Inclusion criteria • High risk infants and children 2 yrs and younger • Hospitalized for RSV, bronchiolitis and/or pneumonia • Positive for RSV antigens • Poorly controlled congestive heart failure before RSV illness • Renal failure • Ventilator dependency before RSV illness • Life expectancy< 6 months from study onset • Treatment with ribavirin before enrollment • Previous adverse reaction to blood products • Known IgA or other immunodeficiency • Enrollment in concurrent RSVIG study • Cystic fibrosis • Asthma • Reactive airway disease w/o BPD • Apnea w/o LRI • Admission for ribavirin therapy Outcome Study design: RCT-P Intervention Group A (n = 51) Inclusion/Exclusion Criteria Mean age at enrollment (yr.± SE) RSVIG: 0.55 ± 0.07 Placebo: 0.58 ± 0.06 Mean gestational age (wk.± SE) RSVIG: 31.0 ± 0.8 Placebo: 30.7 ± 0.7 Comorbidities • Groups balanced at entry for • Significant differences between study groups BPD, congenital heart disease and prematurity. History of LRI significantly more frequent in placebo group (37% for placebo vs. 18% for RSVIG) Quality Quality Excellent 65 Southern Health Clinical Practice Guideline for the Management of Bronchiolitis in Infants and Children RSVIG 30 mL/kg (1.5 mg/kg) IV x 1 dose over 12 hrs Group B (n = 53) Placebo 0.15 mg/kg albumin (identically appearing solution and schedule) Other treatment Supplemental oxygen, mechanical ventilation, ribavirin therapy • Mean duration of hospitalization in days ± SE (RSVIG vs. placebo) 8.41± 0.97 vs. 8.89 ± 0.99 • Mean duration of ICU stay in days ± SE (RSVIG vs. placebo) 9.77± 1.66 (n = 31) vs. 10.27 ± 1.81 (n = 18) • Development of RSV in hospitalized patients during subsequent respiratory season 3/48 (6%) vs. 3/50 (6%) • Readmission during subsequent respiratory season(RSVIG vs. placebo) -5/48 (10%) vs. 6/50 (12%) Secondary outcomes • • • • • • Duration of mechanical ventilation Requirement for supplemental oxygen during hospitalization Change in respiratory scores 24, 48, 72 and 96 hrs after infusion Bronchodilator use Ribavirin use Steroid use Subgroup analysis • Underlying diagnosis • Gestational age, year, center • Respiratory score • ICU stay at entry • No (P = 0.73) • No (P = 0.90) • No (Pvalue NR) • No (Pvalue NR) • No • No • No • No • No • No Significant differences at baseline RSVIG group had more severe disease than placebo group: -ICU admission: 47% vs. 28% (P = 0.03) -Mechanical ventilation: 31% vs. 18% (P = 0.01) -Mean respiratory scores of 4 -5: 45% vs. 29% (P = 0.38) Other comments • No • No • No • No Adverse events • RSVIG -22 events in 16 patients -16/22 possibly drug-related • Placebo -11 events in 10 patients -8/11 events possibly drug-related Guideline Development Process 66 Southern Health Clinical Practice Guideline for the Management of Bronchiolitis in Infants and Children 8.4.8 Analgesics or antipyretics Study Selection Criteria Patient Intervention Infants or children with bronchiolitis Comparison Placebo Analgesics or antipyretics Outcomes Any Study Type Any Language English Characteristics of included studies: Study Study Type N(total) Patients Lesko and Mitchell152 RCT 27,065 Publication Date Acutely febrile children <2 years old seen as outpatients, >1500 with LRI Any Number of included studies: 1 RCT Intervention Comparison Outcomes Paracetamol 12mg/kg Ibuprofen 5mg/kg or 10 mg/kg Hospitalisation, adverse events Lesko and Mitchell152 Yes Yes Yes Yes Yes 4 weeks 0.3% Yes Inclusion of all subjects in analysis Objective & independent assessment of outcomes Proportion lost to follow up Duration of follow-up Blinding – patients/ investigators/ assessors Groups similar at baseline Concealment of allocation Adequate method of randomisation Study Specified inclusion/ exclusion criteria Quality of included studies: Yes Comments • Methodological details provided in a separate, referenced paper which was accessed in full text. Results of included studies: • In the participants with bronchiolitis or asthma, there was no difference in hospitalisation rate between paracetamol and ibuprofen groups. • Analysis of the entire 27,065 cohort found that there were no infants or children hospitalised for acute renal failure, anaphylaxis or Reye’s syndrome. • Three children (all in the ibuprofen group) were hospitalised with evidence of gastrointestinal bleeding. The bleeds were not severe and resolved with conservative management. Guideline Development Process 67 Southern Health Clinical Practice Guideline for the Management of Bronchiolitis in Infants and Children 8.4.9 Chest Physiotherapy Study Selection Criteria Patient Infants or children with bronchiolitis Comparison Any Intervention Chest physiotherapy Outcomes Any Study Type Any Language English Characteristics of included studies: Study Study Type N(total) Patients Perotta et al153 Systematic Review 156 (3 RCTs) Publication Date Infants younger than 24months of age with acute bronchiolitis in all settings Any Number of included studies: 1 SR Intervention Comparison Outcomes Any type of chest physiotherapy: postural drainage, chest percussion, vibration, chest shaking, directed coughing or forced exhalation Standard care (excluding chest physiotherapy) or other drainage or breathing techniques. Change in severity, oxygen saturation, duration of oxygen supplementation, length of hospital stay, use of bronchodilators/steroids 153 Perotta et al Yes Yes Results of included studies: Yes Yes Yes Yes Strengths and limitations of included studies discussed Summary of main results presented Homogeneity between studies assessed Validity of included trials appraised Explicit and comprehensive search strategy Study Specified inclusion/ exclusion criteria Focused research question Quality of included studies: Comments Yes • No significant differences were found between treatment and control groups for any outcome measures. • Trials were not placebo controlled. • The authors concluded that “vibration and percussion techniques have not shown to reduce length of hospital stay in acute bronchiolitis or to improve a severity clinical score” Guideline Development Process 68 Southern Health Clinical Practice Guideline for the Management of Bronchiolitis in Infants and Children 8.4.10 Position Study Selection Criteria Patient Infants or children with bronchiolitis Comparison Any Intervention Position Outcomes Any Study Type Any Language English Characteristics of included studies: Study Study Type N(total) Wells et al162 Sys Rev Publication Date Total of 21 studies (n=436), 1 focused on bronchiolitis (n=17) Any Number of included studies: 1 SR Patients Intervention Comparison Outcomes Infants and children hospitalised with acute respiratory distress Position Any SaO2, PaO2, PCO2, oxygenation index, desaturation episodes, RR, tidal volume, minute volume, work of breathing, dynamic lung compliance, total pulmonary resistance, inspiratory and expiratory resistance, thoracoabdominal synchrony, HR, oesophageal pressure Wells et al162 Yes Yes Yes Yes Yes Yes Strengths and limitations of included studies discussed Summary of main results presented Homogeneity between studies assessed Validity of included trials appraised Explicit and comprehensive search strategy Specified inclusion/ exclusion criteria Study Focused research question Quality of included studies: Yes Comments • 322 patients were preterm neonates, 228 of which were mechanically ventilated • 49 were newborn infants (3 mechanically ventilated) and 65 were aged 1 month – 16 years (20 mechanically ventilated Results of included studies: • The one RCT including infants and children with bronchiolitis did not find a significant difference between prone and supine positions. The RCT is likely to have been underpowered • In the meta-analysis prone positioning was significantly more beneficial than supine positioning in terms of oxygen saturation, partial pressure of arterial oxygen, oxygenation index, thoraco-abdominal synchrony, and episodes of desaturation. There were no statistically significant differences between any other positions. Guideline Development Process 69 Southern Health Clinical Practice Guideline for the Management of Bronchiolitis in Infants and Children 8.4.11 Apnoea Study Selection Criteria Patient Infants or children with bronchiolitis Comparison No apnoea Intervention Apnoea Outcomes Any Study Type Any Language English Characteristics of included studies: Study Study Type N(total) Patients Publication Date Any Number of included studies: 4 case-control 185 Patients <12 months admitted with RSV Gestational age at birth, PCA, sex, birth weight, clinical signs, Sa02, x-ray findings, disease course, apnoea of prematurity Apnoea by history or direct observation Anas et al155 Case-control 32 Patients <18 months admitted with RSV Gestational age at birth, PCA, sex, clinical status, length of illness Apnoea by history or direct observation Bruhn et al156 Case-control 112 Patients <6 months with RSV Gestational age at birth, PCA, sex, clinical signs, cyanosis Apnoea by history or direct observation Church et al157 Case-control 261 Patients <12 months admitted with RSV Gestational age at birth, PCA, sex, birth weight, apnoea of prematurity, Sa02 Apnoea by history or direct observation Objective & independent assessment of exposure Yes Yes Yes Unclear Yes Unclear No Yes • 38 infants with apnoea and 147 without apnoea Yes Yes Yes Unclear Yes Unclear No Yes • Only 5 infants with apnoea and 27 without Bruhn et al No Yes No Unclear Yes Unclear No No • 56 infants with apnoea and 56 without apnoea matched by birth date from larger cohort Church et al157 Yes Yes Yes Unclear Yes Unclear No Yes • 48 infants with apnoea and 213 without apnoea Study Kneyber et al154 155 Anas et al 156 Guideline Development Process Sufficient duration Comparable groups with respect to confounders Controls randomly selected from the source population Explicit definition of cases Specified inclusion/ exclusion criteria Quality of included studies: Inclusion of all subjects in analysis Outcomes Case-control Outcomes assessed blindly with respect to disease status Exposure Kneyber et al154 Comments 70 Southern Health Clinical Practice Guideline for the Management of Bronchiolitis in Infants and Children 8.4.11 Apnoea continued Results of included studies: • Kneyber et al154 found that in multivariate analysis, age at admission was the only significant variable contributing to risk of apnoea. Infants with apnoea were significantly younger than those without (mean 2.3±2.5 vs 3.3±2.8 months, p<0.05). • Anas et al155 found that infants with apnoea had a younger gestational age at birth (33±2 vs 39±2wks, p<0.01), and younger post-conceptional age at admission (37±2 vs 53±8wks, p<0.01) than infants without apnoea • Bruhn et al156 found that apnoeic infants were younger and more apnoeic infants were born at <38 weeks GA than non-apnoeic infants (57% vs 20%, p<0.001). Higher incidence of otitis media and fever in the non-apnoeic group. Higher incidence of cyanosis in the apnoeic group. • Church et al157 found that apnoeic infants were younger (2 vs 3months, p<0.005) and more likely to have been born at ≤37weeks (58% vs 26%, p<0.005), they were also more likely to have a history of apnoea of prematurity (90% vs 45%, p<0.05) Guideline Development Process 71 Southern Health Clinical Practice Guideline for the Management of Bronchiolitis in Infants and Children 9. References 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 1. 13. 14. 15. 16. Glezen WP, Taber LH, Frank AL, Kasel JA. Risk of primary infection and reinfection with respiratory syncytial virus. Am J Dis Child.1986;140:543-546. Eriksson M, Bennet R, Rotzen-Ostlund M, von Sydow M, Wirgart BZ. Populationbased rates of severe respiratory syncytial virus infection in children with and without risk factors, and outcome in a tertiary care setting. Acta Paediatr. 2002;91:593-598. Wang EE, Law BJ, Stephens D. Pediatric Investigators Collaborative Network on Infections in Canada (PICNIC) prospective study of risk factors and outcomes in patients hospitalized with respiratory syncytial viral lower respiratory tract infection. J Pediatr. 1995;126:212-9. Hall CB. Respiratory syncytial virus and parainfluenza virus. N Engl J Med. 2001;344:1917-1928. Shay DK, Holman RC, Newman RD, Liu LL, Stout JW, Anderson LJ. Bronchiolitis associated hospitalizations among US children, 1980-1996. JAMA. 1999;282:1440- 1446. American Academy of Pediatrics. Respiratory Syncytial Virus. In: Pickering LK, ed. 2000 Red Book: Report of the Committee on Infectious Diseases. 25th ed. Elk Grove Village, Il: American Academy of Pediatrics; 2000:484. Perlstein PH, Kotagal UR, Bolling C, et al. Evaluation of an evidence-based guideline for bronchiolitis. Pediatrics. 1999;104:1334-1341. Committee on Infectious Diseases. Reassessment of the indications for ribavirin therapy in respiratory syncytial virus infections. Pediatrics. 1996;97:37140. Flores G, Horwitz RI. Efficacy of beta2agonists in bronchiolitis: a reappraisal and meta-analysis. Pediatrics. 1997;100:233239. Kellner JD, Ohlsson A, Gadomski AM, Wang EE. Bronchodilators for bronchiolitis. Cochrane Database Syst Rev. 2000;CD001266. Garrison MM, Christakis DA, Harvey E, Cummings P, Davis RL. Systemic corticosteroids in infant bronchiolitis: A metaanalysis. Pediatrics. 2000;105:E44. American Academy of Pediatrics Committee on Infectious Diseases and Committee of Fetus and Newborn. Prevention of respiratory syncytial virus infections: indications for the use of palivizumab and update on the use of RSV-IGIV. Pediatrics. 1998;102:1211-1216. Joffe S, Ray GT, Escobar GJ, Black SB, Lieu TA. Cost-effectiveness of respiratory syncytial virus prophylaxis among preterm infants. Pediatrics. 1999;104:419-427. Lofland JH, O'Connor JP, Chatterton ML, et al. Palivizumab for respiratory syncytial virus prophylaxis in high-risk infants: a costeffectiveness analysis. Clin Ther. 2000;22:1357-1369. Carande-Kulis VG, Maciosek MV, Briss PA, et al. Methods for systematic reviews of economic evaluations for the Guide to Community Preventive Services. Task Force on Community Preventive Services. Am J Prev Med. 2000;18:75-91. Centers for Disease Control. The Community Guide: Guide to Community Preventive Services. 1996. Web Page. Available at: http://www.thecommunityguide.org/PDFS/ References 17. 18. 19. 20. 21. 22. 23. 24. 25. 26. 27. 28. 29. 30. ECONEVAL_version 3.pdf. Last accessed October 14, 2002 Richardson WS, Wilson M, Moyer V, Naylor CD. Diagnosis - Clinical Manifestations of Disease . In: Guyatt G, Rennie D, eds. User's Guide to the Medical Literature: A Manual for Evidence-Based Clinical Practice. Chicago, Ill: American Medical Association; 2002:449- 516. West SL, King V, Carey TS, et al. Systems to Rate the Strength of Scientific Evidence. Evidence Report, Technology Assessment No. 47. Rockville, Md.: Agency for Healthcare Research and Quality. AHRQ Publication No. 02-E016; 2002. Court SD. The definition of acute respiratory illnesses in children. Postgrad Med J. 1973;49:771-776. Randolph AG, Wang EE. Ribavirin for respiratory syncytial virus lower respiratory tract infection. A systematic overview. Arch Pediatr Adolesc Med. 1996;150:942-947. Klassen TP, Rowe PC, Sutcliffe T, Ropp LJ, McDowell IW, Li MM. Randomized trial of salbutamol in acute bronchiolitis. J Pediatr. 1991;118:807-811. Menon K, Sutcliffe T, Klassen TP. A randomized trial comparing the efficacy of epinephrine with salbutamol in the treatment of acute bronchiolitis. J Pediatr. 1995;126:1004-1007. Schuh S, Coates AL, Binnie R, et al. Efficacy of oral dexamethasone in outpatients with acute bronchiolitis. J Pediatr. 2002;140:27-32. Can D, Inan G, Yendur G, Oral R, Gunay I. Salbutamol or mist in acute bronchiolitis. Acta Paediatr Jpn. 1998;40:252-255. Rodriguez WJ , Gruber WC, Groothuis JR, et al. Respiratory syncytial virus immune globulin treatment of RSV lower respiratory tract infection in previously healthy children. Pediatrics. 1997;100:937-942. Ahluwalia G, Embree J, McNicol P, Law B, Hammond GW. Comparison of nasopharyngeal aspirate and nasopharyngeal swab specimens for respiratory syncytial virus diagnosis by cell culture, indirect immunofluorescence assay, and enzymelinked immunosorbent assay. J Clin Microbiol. 1987;25:763-767. Chattopadhya D, Chatterjee R, Anand VK, Kumari S, Patwari AK. Lower respiratory tract infection in hospitalized children due to respiratory syncytial (RS) virus during a suspected epidemic period of RS virus in Delhi. J Trop Pediatr. 1992;38:68-73. Eugene-Ruellan G, Freymuth F, Bahloul C, Badrane H, Vabret A, Tordo N. Detection of respiratory syncytial virus A and B and parainfluenzavirus 3 sequences in respiratory tracts of infants by a single PCR with primers targeted to the L-polymerase gene and differential hybridization. J Clin Microbiol. 1998;36:796-801. Ong GM, Wyatt DE, O'Neill HJ, McCaughey C, Coyle PV. A comparison of nested polymerase chain reaction and immunofluorescence for the diagnosis of respiratory infections in children with bronchiolitis, and the implications for a cohorting strategy. J Hosp Infect. 2001;49:122-128. Waner JL, Whitehurst NJ, Todd SJ, Shalaby H, Wall LV. Comparison of directigen RSV with viral isolation and direct immunofluorescence for the identification of respiratory syncytial virus. J Clin Microbiol. 1990;28:480-483. 72 Southern Health Clinical Practice Guideline for the Management of Bronchiolitis in Infants and Children 31. Lozano J.M., Wang E. Bronchiolitis. Clin Evid . 2002;272-282. 32. Shaw KN, Bell LM, Sherman NH. Outpatient assessment of infants with bronchiolitis. Am J Dis Child. 1991;145:151-155. 33. Mulholland EK, Olinsky A, Shann FA. Clinical findings and severity of acute bronchiolitis. Lancet. 1990;335:12591261. 34. Cherian T, Steinhoff MC, Simoes EA, John TJ. Clinical signs of acute lower respiratory tract infections in malnourished infants and children. Pediatr Infect Dis J. 1997;16:490494. 35. Saijo M, Ishii T, Kokubo M, Murono K, Takimoto M, Fujita K. White blood cell count, C-reactive protein and erythrocyte sedimentation rate in respiratory syncytial virus infection of the lower respiratory tract. Acta Paediatr Jpn. 1996;38:596-600. 36. Dawson KP, Long A, Kennedy J, Mogridge N. The chest radiograph in acute bronchiolitis. J Paediatr Child Health. 1990;26:209-211. 37. Dobson JV, Stephens-Groff SM, McMahon SR, Stemmler MM, Brallier SL, Bay C. The use of albuterol in hospitalized infants with bronchiolitis. Pediatrics. 1998;101:361368. 38. Friis B, Eiken M, Hornsleth A, Jensen A. Chest X-ray appearances in pneumonia and bronchiolitis. Correlation to virological diagnosis and secretory bacterial findings. Acta Paediatr Scand. 1990;79:219-225. 39. Luchetti M, Casiraghi G, Valsecchi R, Galassini E, Marraro G. Porcine-derived surfactant treatment of severe bronchiolitis. Acta Anaesthesiol Scand. 1998;42:805-810. 40. Nasr SZ, Strouse PJ, Soskolne E, et al. Efficacy of recombinant human deoxyribonuclease I in the hospital management of respiratory syncytial virus bronchiolitis. Chest. 2001;120:203-208. 41. Rodriguez WJ , Gruber WC, Welliver RC, et al. Respiratory syncytial virus (RSV) immune globulin intravenous therapy for RSV lower respiratory tract infection in infants and young children at high risk for severe RSV infections: Respiratory Syncytial Virus Immune Globulin Study Group. Pediatrics. 1997;99:454-461. 42. Rodriguez WJ , Kim HW, Brandt CD, et al. Aerosolized ribavirin in the treatment of patients with respiratory syncytial virus disease. Pediatr Infect Dis J. 1987;6:159163. 43. Roosevelt G, Sheehan K, Grupp-Phelan J, Tanz RR, Listernick R. Dexamethasone in bronchiolitis: a randomised controlled trial. Lancet. 1996;348:292-295. 44. Schuh S, Canny G, Reisman JJ, et al. Nebulized albuterol in acute bronchiolitis. J Pediatr. 1990;117:633-637. 45. Taber LH, Knight V, Gilbert BE, et al. Ribavirin aerosol treatment of bronchiolitis associated with respiratory syncytial virus infection in infants. Pediatrics. 1983;72:613- 618. 46. Barry W, Cockburn F, Cornall R, Price JF, Sutherland G, Vardag A. Ribavirin aerosol for acute bronchiolitis. Arch Dis Child. 1986;61:593-597. 47. Chipps BE, Sullivan WF, Portnoy JM. Alpha2A-interferon for treatment of bronchiolitis caused by respiratory syncytial virus. Pediatr Infect Dis J. 1993;12:653-658. 48. De Boeck K, Van der Aa N, Van Lierde S, Corbeel L, Eeckels R. Respiratory syncytial virus bronchiolitis: a double-blind dexamethasone efficacy study. J Pediatr. 1997;131:919-921. References 49. Friis B, Andersen P, Brenoe E, et al. Antibiotic treatment of pneumonia and bronchiolitis. A prospective randomised study. Arch Dis Child. 1984;59:1038-1045. 50. Kjolhede CL, Chew FJ, Gadomski AM, Marroquin DP. Clinical trial of vitamin A as adjuvant treatment for lower respiratory tract infections. J Pediatr. 1995;126:807812. 51. Kong XT, Fang HT, Jiang GQ, Zhai SZ, O'Connell DL, Brewster DR. Treatment of acute bronchiolitis with Chinese herbs. Arch Dis Child. 1993;68:468-471. 52. Kristjansson S, Lodrup Carlsen KC, Wennergren G, Strannegard IL, Carlsen KH. Nebulised racemic adrenaline in the treatment of acute bronchiolitis in infants and toddlers. Arch Dis Child. 1993;69:650654. 53. Bertrand P, Aranibar H, Castro E, Sanchez I. Efficacy of nebulized epinephrine versus salbutamol in hospitalized infants with bronchiolitis. Pediatr Pulmonol. 2001;31:284- 288. 54. Reijonen T, Korppi M, Pitkakangas S, Tenhola S, Remes K. The clinical efficacy of nebulized racemic epinephrine and albuterol in acute bronchiolitis. Arch Pediatr Adolesc Med. 1995;149:686-692. 55. Sanchez I, De Koster J, Powell RE, Wolstein R, Chernick V. Effect of racemic epinephrine and salbutamol on clinical score and pulmonary mechanics in infants with bronchiolitis. J Pediatr. 1993;122:145151. 56. Schweich PJ, Hurt TL, Walkley EI, Mullen N, Archibald LF. The use of nebulized albuterol in wheezing infants. Pediatr Emerg Care. 1992;8:184-188. 57. Hickey RW, Gochman RF, Chande V, Davis HW. Albuterol delivered via metered-dose inhaler with spacer for outpatient treatment of young children with wheezing. Arch Pediatr Adolesc Med. 1994;148:189194. 58. Cengizlier R , Saraclar Y, Adalioglu G, Tuncer A. Effect of oral and inhaled salbutamol in infants with bronchiolitis. Acta Paediatr Jpn. 1997;39:61-63. 59. Gadomski AM, Lichenstein R, Horton L, King J, Keane V, Permutt T. Efficacy of albuterol in the management of bronchiolitis. Pediatrics. 1994;93:907-912. 60. Gadomski AM, Aref GH, el Din OB, el Sawy IH, Khallaf N, Black RE. Oral versus nebulized albuterol in the management of bronchiolitis in Egypt. J Pediatr. 1994;124:131-138. 61. Goh A, Chay OM, Foo AL, Ong EK. Efficacy of bronchodilators in the treatment of bronchiolitis. Singapore Med J. 1997;38:326- 328. 62. Ho L, Collis G, Landau LI, Le Souef PN. Effect of salbutamol on oxygen saturation in bronchiolitis. Arch Dis Child. 1991;66:1061- 1064. 63. Chowdhury D, al Howasi M, Khalil M, alFrayh AS, Chowdhury S, Ramia S. The role of bronchodilators in the management of bronchiolitis: a clinical trial. Ann Trop Paediatr. 1995;15:77-84. 64. Schuh S, Johnson D, Canny G, et al. Efficacy of adding nebulized ipratropium bromide to nebulized albuterol therapy in acute bronchiolitis. Pediatrics. 1992;90:920-923. 65. Wang EE, Milner R, Allen U, Maj H. Bronchodilators for treatment of mild bronchiolitis: a factorial randomised trial. Arch Dis Child. 1992;67:289-293. 66. Goebel J, Estrada B, Quinonez J, Nagji N, Sanford D, Boerth RC. Prednisolone plus albuterol versus albuterol alone in mild to 73 Southern Health Clinical Practice Guideline for the Management of Bronchiolitis in Infants and Children 67. 68. 69. 70. 71. 72. 73. 74. 75. 76. 77. 78. 79. 80. 81. moderate bronchiolitis. Clin Pediatr. 2000;39:213-220. van Woensel JB, Kimpen JL, Sprikkelman AB, Ouwehand A, van Aalderen WM. Longterm effects of prednisolone in the acute phase of bronchiolitis caused by respiratory syncytial virus. Pediatr Pulmonol. 2000;30:92-96. van Woensel JB, Wolfs TF, van Aalderen WM, Brand PL, Kimpen JL. Randomised double blind placebo controlled trial of prednisolone in children admitted to hospital with respiratory syncytial virus bronchiolitis. Thorax. 1997;52:634-637. Klassen TP, Sutcliffe T, Watters LK, Wells GA, Allen UD, Li MM. Dexamethasone in salbutamol-treated inpatients with acute bronchiolitis: a randomized, controlled trial. J Pediatr. 1997;130:191-196. Berger I, Argaman Z, Schwartz SB, et al. Efficacy of corticosteroids in acute bronchiolitis: short-term and long-term followup. Pediatr Pulmonol. 1998;26:162166. Cade A, Brownlee KG, Conway SP, et al. Randomised placebo controlled trial of nebulised corticosteroids in acute respiratory syncytial viral bronchiolitis. Arch Dis Child. 2000;82:126-130. Daugbjerg P, Brenoe E, Forchhammer H, et al. A comparison between nebulized terbutaline, nebulized corticosteroid and systemic corticosteroid for acute wheezing in children up to 18 months of age. Acta Paediatr. 1993; 82:547-51. Fox GF, Everard ML, Marsh MJ, Milner AD. Randomised controlled trial of budesonide for the prevention of post-bronchiolitis wheezing. Arch Dis Child. 1999;80:343347. Kajosaari M, Syvanen P, Forars M, Juntunen-Backman K. Inhaled corticosteroids during and after respiratory syncytial virusbronchiolitis may decrease subsequent asthma. Pediatr Allergy Immunol. 2000;11:198-202. Reijonen T, Korppi M, Kuikka L, Remes K. Anti-inflammatory therapy reduces wheezing after bronchiolitis. Arch Pediatr Adolesc Med. 1996;150:512-517. Richter H, Seddon P. Early nebulized budesonide in the treatment of bronchiolitis and the prevention of postbronchiolitic wheezing. J Pediatr. 1998;132:849-853. Wong JY, Moon S, Beardsmore C, O'Callaghan C, Simpson H. No objective benefit from steroids inhaled via a spacer in infants recovering from bronchiolitis. Eur Respir J. 2000;15:388-394. Everard ML, Swarbrick A, Rigby AS, Milner AD. The effect of ribavirin to treat previously healthy infants admitted with acute bronchiolitis on acute and chronic respiratory morbidity. Respir Med. 2001;95:275-280. Guerguerian AM, Gauthier M, Lebel MH, Farrell CA, Lacroix J. Ribavirin in ventilated respiratory syncytial virus bronchiolitis. A randomized, placebo-controlled trial. Am J Respir Crit Care Med. 1999;160:829-834. Janai HK, Stutman HR, Zaleska M, et al. Ribavirin effect on pulmonary function in young infants with respiratory syncytial virus bronchiolitis. Pediatr Infect Dis J. 1993;12:214-218. Rodriguez WJ , Arrobio J, Fink R, Kim HW, Milburn C. Prospective follow-up and pulmonary functions from a placebo controlled randomized trial of ribavirin therapy in respiratory syncytial virus bronchiolitis. Ribavirin Study Group. Arch Pediatr Adolesc Med. 1999;153:469-474. References 82. Klein M. Multicenter trial of cefpodoxime proxetil vs. amoxicillin -clavulanate in acute lower respiratory tract infections in childhood. International Study Group. Pediatr Infect Dis J. 1995;14:S19-S22. 83. Andrade MA, Hoberman A, Glustein J, Paradise JL, Wald ER. Acute otitis media in children with bronchiolitis. Pediatrics. 1998;101:617-619. 84. Hollman G, Shen G, Zeng L, et al. Helium oxygen improves Clinical Asthma Scores in children with acute bronchiolitis. Crit Care Med. 1998;26:1731-1736. 85. Van Bever HP , Desager KN, Pauwels JH, Wojciechowski M, Vermeire PA. Aerosolized furosemide in wheezy infants: a negative report. Pediatr Pulmonol. 1995;20:16-20. 86. Groothuis JR , Simoes EA, Hemming VG. Respiratory syncytial virus (RSV) infection in preterm infants and the protective effects of RSV immune globulin (RSVIG). Respiratory Syncytial Virus Immune Globulin Study Group. Pediatrics. 1995;95:463-467. 87. Groothuis JR , Simoes EA, Levin MJ, et al. Prophylactic administration of respiratory syncytial virus immune globulin to highrisk infants and young children. The Respiratory Syncytial Virus Immune Globulin Study Group. N Engl J Med. 1993;329:1524-1530. 88. Simoes EA, Sondheimer HM, Top FHJ, et al. Respiratory syncytial virus immune globulin for prophylaxis against respiratory syncytial virus disease in infants and children with congenital heart disease. The Cardiac Study Group. J Ped. 1998;133:492-499. 89. The PREVENT Study Group. Reduction of respiratory syncytial virus hospitalization among premature infants and infants with bronchopulmonary dysplasia using respiratory syncytial virus immune globulin prophylaxis. Pediatrics. 1997;99:93-99. 90. Groothuis JR . Safety and tolerance of palivizumab administration in a large Northern Hemisphere trial. Northern Hemisphere Expanded Access Study Group. Pediatr Infect Dis J . 2001;20:628630. 91. The IMpact-RSV Study Group. Palivizumab, a humanized respiratory syncytial virus monoclonal antibody, reduces hospitalization from respiratory syncytial virus infection in high-risk infants. Pediatrics. 1998;102:531- 537. 92. Meissner HC, Groothuis JR, Rodriguez WJ, et al. Safety and pharmacokinetics of an intramuscular monoclonal antibody (SB 209763) against respiratory syncytial virus (RSV) in infants and young children at risk for severe RSV disease. Antimicrob Agents Chemother. 1999;43:1183-1188. 93. Groothuis JR , King SJ, Hogerman DA, Paradiso PR, Simoes EA. Safety and immunogenicity of a purified F protein respiratory syncytial virus (PFP-2) vaccine in seropositive children with bronchopulmonary dysplasia. J Infect Dis. 1998;177:467-469. 94. Piedra PA, Grace S, Jewell A, et al. Purified fusion protein vaccine protects against lower respiratory tract illness during respiratory syncytial virus season in children with cystic fibrosis. Pediatr Infect Dis J. 1996;15:23-31. 95. Piedra PA, Grace S, Jewell A, et al. Sequential annual administration of purified fusion protein vaccine against respiratory syncytial virus in children with cystic fibrosis. Pediatr Infect Dis J. 1998;17:217-224. 74 Southern Health Clinical Practice Guideline for the Management of Bronchiolitis in Infants and Children 96. Marchetti A, Lau H, Magar R, Wang L, Devercelli G. Impact of palivizumab on expected costs of respiratory syncytial virus infection in preterm infants: potential for savings. Clin Ther. 1999;21:752-766. 97. Numa A. Outcome of respiratory syncytial virus infection and a cost-benefit analysis of prophylaxis. J Paediatr Child Health. 2000;36:422-427. 98. Schrand LM, Elliott JM, Ross MB, Bell EF, Mutnick AH. Cost-benefit analysis of RSV prophylaxis in high-risk infants. Ann Pharmacother. 2001;35:1186-1193. 99. Groothuis JR, Gutierrez KM, Lauer BA. Respiratory syncytial virus infection in children with bronchopulmonary dysplasia. Pediatrics. 1988;82:199-203. 100. Farina D, Rodriguez SP, Bauer G, et al. Respiratory syncytial virus prophylaxis: costeffective analysis in Argentina. Pediatr Infect Dis J. 2002;21:287-291. 101. Sorrentino M, Powers T. Effectiveness of palivizumab: evaluation of outcomes from the 1998 to 1999 respiratory syncytial virus season. The Palivizumab Outcomes Study Group. Pediatr Infect Dis J. 2000;19:1068- 1071. 102. Cunningham CK, McMillan JA, Gross SJ. Rehospitalization for respiratory illness in infants of less than 32 weeks' gestation. Pediatrics. 1991;88:527-532. 103. Paul DA, Leef KH, Chidekel A, Tran K, Eppes S, Stefano JL . Home delivery of palivizumab: outcomes and compliance in regional preterm infants. Del Med J. 2002;74:11-15. 104. Joffe S, Lieu T. Pallivizumab (Synagis): Counting "costs" and values. Pediatrics. 1999;106:1168. 105. Engle S, Newns GH. Proliferative mural bronchiolitis. Arch Dis Child. 1940;15:219. 106. Denny FW, Clyde WA. Acute lower respiratory tract infections in nonhospitalized children. J Pediatr. 1986;108:635-646. 107. Perlstein PH, Kotagal UR, Schoettker PJ, et al. Sustaining the implementation of an evidencebased guideline for bronchiolitis. Arc Pediatr Adolesc Med. 2000;154:10011007. 108. Gold M. Panel on cost-effectiveness in health and medicine. Med Care. 1996;34:DS197- DS199. 109. Wohl ME. Bronchiolitis. Pediatr Ann. 1986;15:307-309, 312-313. 110. Lowell DI, Lister G, Von Koss H, McCarthy P. Wheezing in infants: the response to epinephrine. Pediatrics. 1987;79:939-945. 111. Wang EE, Milner RA, Navas L, Maj H. Observer agreement for respiratory signs and oximetry in infants hospitalized with lower respiratory infections. Am Rev Respir Dis. 1992;145:106-109. 112. Tal A, Bavilski C, Yohai D, Bearman JE, Gorodischer R, Moses SW. Dexamethasone and salbutamol in the treatment of acute wheezing in infants. Pediatrics. 1983;71:13-8. 113. Tal A, Sanchez I, Pasterkamp H. Respirosonography in infants with acute bronchiolitis. Am J Dis Child. 1991;145:1405- 1410. 114. Westley CR, Cotton EK, Brooks JG. Nebulized racemic epinephrine by IPPB for the treatment of croup: a double-blind study. Am J Dis Child. 1978;132:484-487. 115. Wood DW, Downes JJ, Lecks HI. A clinical scoring system for the diagnosis of respiratory failure. Preliminary report on childhood status asthmaticus. Am J Dis Child. 1972;123:227- 228. References 116. Bruhn FW, Yeager AS. Respiratory syncytial virus in early infancy. Circulating antibody and the severity of infection. Am J Dis Child . 1977;131:145-148. 117. The AGREE Instrument, 2004. The AGREE Collaboration http://www.agreecollaboration.org/instrum ent/ 118. Viswanathan M, King VJ, Bordley C, Honeycutt AA, Wittenborn J, Jackman AM, Sutton SF, Lohr KN. 2003. Management of bronchiolitis in infants and children. Evidence Report / Technology Assessment Number 69. Agency for Healthcare Research and Quality. www.ahrq.com 119. Australian Institute of Health and Welfare.(2003-04) Interactive national hospital morbidity data, Australian Government, http://www.aihw.gov.au/hospitals/datacub es/index.cfm. 120. Plint AC, Johnson DW, Wiebe N, Bulloch B, Pusic M, Joubert G, Pianosi P, Turner T, Thompson G and Klassen TP. Practice variation among pediatric emergency departments in the treatment of bronchiolitis. Academic Emergency Medicine 2004;11:353-60. 121. Swingler GH, Hussey GD and Zwarenstein, M. Duration of illness in ambulatory children diagnosed with bronchiolitis Archives of Pediatrics & Adolescent Medicine. 2000;154:997-1000. 122. Landau LI. Definitions and early natural history Med J Aust, 2002; 177: Suppl, S389. 123. Christakis DA, Cowan CA, Garrison MM, Molteni R, Marcuse E and Zerr DM. Variation in inpatient diagnostic testing and management of bronchiolitis Pediatrics, 2005;115:878-84. 124. Macfarlane P, Denham J, Assous J and Hughes C. RSV testing in bronchiolitis: which nasal sampling method is best? Archives of Disease in Childhood; 2005:90, 634-5. 125. Purcell K, Fergie J. Concurrent serious bacterial infections in 912 infants and children hospitalized for treatment of respiratory syncytial virus lower respiratory tract infection. Pediatric Infectious Disease Journal 2004;23(3):267-9. 126. Levine DA, Platt SL, Dayan PS, Macias CG, Zorc JJ, Krief W, et al. Risk of serious bacterial infection in young febrile infants with respiratory syncytial virus infections. Pediatrics 2004;113(6):1728-34. 127. Tsolia MN, Kafetzis D, Danelatou K, Astral H, Kallergi K, Spyridis P, et al. Epidemiology of respiratory syncytial virus bronchiolitis in hospitalized infants in Greece. European Journal of Epidemiology 2003;18(1):55-61. 128. Melendez E, Harper MB. Utility of sepsis evaluation in infants 90 days of age or younger with fever and clinical bronchiolitis. Pediatric Infectious Disease Journal 2003;22(12):1053-6. 129. Lukic-Grlic A, Bace A, Lokar-Kolbas R, Loffler-Badzek D, Drazenovic V, Bozikov J, et al. Clinical and epidemiological aspects of respiratory syncytial virus lower respiratory tract infections. Eur J Epidemiol 1999;15(4):361-5. 130. Liebelt EL, Qi K, Harvey K. Diagnostic testing for serious bacterial infections in infants aged 90 days or younger with bronchiolitis. Archives of Pediatrics & Adolescent Medicine 1999;153(5):525-30. 131. Greenes DS, Harper MB. Low risk of bacteremia in febrile children with recognizable viral syndromes. Pediatric 75 Southern Health Clinical Practice Guideline for the Management of Bronchiolitis in Infants and Children Infectious Disease Journal 1999;18(3):258-61. 132. Antonow JA, Hansen K, McKinstry CA, Byington CL. Sepsis evaluations in hospitalized infants with bronchiolitis. Pediatr Infect Dis J 1998;17(3):231-6. 133. Kuppermann N, Bank DE, Walton EA, Senac MO, Jr., McCaslin I. Risks for bacteremia and urinary tract infections in young febrile children with bronchiolitis. Archives of Pediatrics & Adolescent Medicine 1997;151(12):1207-14. 134. Davies HD, Matlow A, Petric M, Glazier R, Wang EE. Prospective comparative study of viral, bacterial and atypical organisms identified in pneumonia and bronchiolitis in hospitalized Canadian infants. Pediatric Infectious Disease Journal 1996;15(4):371-5. 135. Sunakorn P, Chunchit L, Niltawat S, Wangweerawong M, Jacobs RF. Epidemiology of acute respiratory infections in young children from Thailand. Pediatric Infectious Disease Journal 1990;9(12):873-7. 136. Aggarwal S, Agarwal KC, Bhakoo ON. A bacteriological study of acute lower respiratory tract infections in infancy and childhood. Indian Pediatrics 1969;6(12):747-58. 137. Walsh P, Rothenberg SJ, O'Doherty S, Hoey H, Healy R. A validated clinical model to predict the need for admission and length of stay in children with acute bronchiolitis. European Journal of Emergency Medicine 2004;11(5):265-72. 138. El-Radhi AS, Barry W, Patel S. Association of fever and severe clinical course in bronchiolitis. Archives of Disease in Childhood 1999;81(3):231-4. 139. Flores P, Rebelo-de-Andrade H, Goncalves P, Guiomar R, Carvalho C, Sousa EN, et al. Bronchiolitis caused by respiratory syncytial virus in an area of portugal: epidemiology, clinical features, and risk factors. European Journal of Clinical Microbiology & Infectious Diseases 2004;23(1):39-45. 140. Lebel MH, Gauthier M, Lacroix J, Rousseau E, Buithieu M. Respiratory failure and mechanical ventilation in severe bronchiolitis. Archives of Disease in Childhood 1989;64(10):1431-7. 141. Mai TV, Selby AM, Simpson JM, Isaacs D. Use of simple clinical parameters to assess severity of bronchiolitis. Journal of Paediatrics & Child Health 1995;31(5):4658. 142. Mulholland EK, Olinsky A, Shann FA. Clinical findings and severity of acute bronchiolitis. Lancet 1990;335(8700):1259-61. 143. Shaw KN, Bell LM, Sherman NH. Outpatient assessment of infants with bronchiolitis. American Journal of Diseases of Children 1991;145(2):151-5. 144. Hartling L, Wiebe N, Russell K, Patel H, Klassen TP. Epinephrine for bronchiolitis. The Cochrane Library. 2005;3. 145. King VJ, Viswanathan M, Bordley WC, Jackman AM, Sutton SF, Lohr KN, et al. Pharmacologic treatment of bronchiolitis in infants and children: a systematic review.[see comment]. Archives of Pediatrics & Adolescent Medicine 2004;158(2):127-37. 146. Patel H, Platt R, Lozano JM, Wang EEL. Glucocorticoids for acute viral bronchiolitis in infants and young children. The Cochrane Library. 2005;3. References 147. Davison C, Ventre KM, Luchetti M, Randolph AGg. Efficacy of interventions for bronchiolitis in critically ill infants: a systematic review and meta-analysis. Pediatr Crit Care Med 2004;5(5):482-9. 148. Zhang L, Ferruzzi E, Bonfanti T, Auler MI, D'Avila N E, Faria CS, et al. Long and short-term effect of prednisolone in hospitalized infants with acute bronchiolitis. Journal of Paediatrics & Child Health 2003;39(7):548-51. 149. Kuyucu S, Unal S, Kuyucu N, Yilgor E. Additive effects of dexamethasone in nebulized salbutamol or L-epinephrine treated infants with acute bronchiolitis. Pediatrics International 2004;46(5):53944. 150. Renzi P, Marcotte JE, Berube D, Bjornson C, Spier S. Effect of nebulized budesonide for 10 weeks on the development of asthma after acute bronchiolitis in infants [abstract]. In: American Thoracic Society 99th International Conference.; 2003; Seattle, USA; 2003. 151. Ventre K, Randolph AG. Ribavirin for respiratory syncytial virus infection of the lower respiratory tract in infants and young children [Systematic Review]. Cochrane Database of Systematic Reviews 2005;4:4. 152. Lesko SM, Mitchell AA. The safety of acetaminophen and ibuprofen among children younger than two years old. Pediatrics 1999;104(4):e39. 153. Perrotta C, Ortiz Z, Roque Mg. Chest physiotherapy for acute bronchiolitis in paediatric patients between 0 and 24 months old. Cochrane Database Syst Rev. 2005(2):CD004873. 154. Kneyber MC, Brandenburg AH, de Groot R, Joosten KF, Rothbarth PH, Ott A, et al. Risk factors for respiratory syncytial virus associated apnoea. European Journal of Pediatrics. 1998 Apr;157(4):331-5. 155. Anas N, Boettrich C, Hall CB, Brooks JG. The association of apnea and respiratory syncytial virus infection in infants. J Pediatr. 1982 Jul;101(1):65-8. 156. Bruhn FW, Mokrohisky ST, McIntosh K. Apnea associated with respiratory syncytial virus infection in young infants. J Pediatr. 1977 Mar;90(3):382-6. 157. Church NR, Anas NG, Hall CB, Brooks JG. Respiratory syncytial virus-related apnea in infants. Demographics and outcome. Am J Dis Child. 1984 Mar;138(3):247-50. 158. Tobias JD. Caffeine in the treatment of apnea associated with respiratory syncytial virus infection in neonates and infants. South Med J. 2000 Mar;93(3):294-6. 159. Johnston DM, Kuzemko JA. Virus-induced apnoea and theophylline. Lancet. 1992 Nov 28;340(8831):1352. 160. DeBuse P, Cartwright D. Respiratory syncytial virus with apnoea treated with theophylline. Med J Aust. 1979 Sep 22;2(6):307-8. 161. Sajit NT, Steggall M, Padmakumar B. Apnoeas in bronchiolitis: is there a role for caffeine? Arch Dis Child. 2005 Apr;90(4):438. 162. Wells DA, Gillies D, Fitzgerald DA. Positioning for acute respiratory distress in hospitalised infants and children. Cochrane Database of Systematic Reviews. 2005(4). 163. Scottish Intercollegiate Guideline Network, 2004, SIGN 50: A guideline developers' handbook. 76 Southern Health Clinical Practice Guideline for the Management of Bronchiolitis in Infants and Children Annex 1 Management of Bronchiolitis in Hospital DIAGNOSIS Consider alternate diagnoses in a child who presents with: • Recurrent wheezing • Cough as the predominant • Persistent, or repeated a • Failure to thrive • Cardiac murmur, oedema • Sudden onset of symptom wheeze, loss of voice, or differential air entry Trial Of Bronchodilator Therapy A child with bronchiolitis-like symptoms who responds to treatment with a bronchodilator is likely to have asthma. s in patients older than 9 months, particularly with recurrent wheezing. rologic tests should NOT be used to diagnose bronchiolitis. h: al signs and symptoms of an upper respiratory tract infection h ypnoea ratory crepitations eze ASSESSMENT OF SEVERITY OF DISEASE Moderate mal Severe Increased • respiratory rate r increased respiratory rate Minor • Markedly • Moderate/marked • accessory muscle use accessory muscle use • • • re • M • Nasal flare and/or grunting mal • to • heart rate# feeding Increased • Difficulty • • increased heart rate# Minor • dehydration Markedly Unable to feed Marked dehydration Crepitations • gen • saturation 90-95% Oxygen Toxic appearance Sweaty Irritable • • • • saturation <90% Oxygen N.B. If patient has signs or symptoms across categories, always treat according to their most severe features. Treatment should not be based on a child’s oxygen saturation alone. <36 weeks gestation, and those who have underlying cardiorespiratory disease as they have an increased risk of more severe disease and apnoea. Consider virolo INITIAL TREATMENT • Consult senior • Give oxygen if • medical staff • Int saturation <90% oxy Consider • Consider oxygen oxygen if child is <3 months old, has increased work of if child is <3 months old, has increased work of breathing, breathing, decreased oxygenation during feeds or saturation 90decreased oxygenation during feeds or saturation 90-92% 92% Give oxygen at the lowest flow rate required to maintain saturations between 92-95%. If requiring oxygen at >0.5L/min, provide continuous pulse oximetry. • If requiring oxygen therapy above 40%, consult ICU. • Encourage • Consider • small frequent feeds nasogastric (NG) usual fluids or intravenous (IV) fluids if increased int • If not work of breathing tolerating oral feeds, consider nasogastric (NG) usual fluids or • If circulatory • intravenous (IV) fluids if increased work of breathing compromise or severe dehydration discuss fluids with senior medical cir staff wit If providing IV fluids give glucose 5% & sodium chloride 0.9% at 75% of maintenance rates and take blood for assessment of glucose, urea, ele • Consider blood • gas analysis blo • If nasal • If nasal • congestion, trial saline nasal drops & consider suctioning congestion, trial saline nasal drops & consider suctioning urg • urage harge eason ) Discharge • if NOT requiring oxygen or NG or IV fluids Reassess within 1 • hour wit If reason • Annexes • 77 Southern Health Clinical Practice Guideline for the Management of Bronchiolitis in Infants and Children not to discharge, reassess within 1 hour ONGOING TREATMENT IF DETERIORATING: • • • de oxygen and/or fluid therapy as per above criteria harge when not requiring oxygen or fluid therapy de patient information, including reasons to return to hospital or post letter to GP and other relevant specialists Consult senior paediatric Reconsider diagnosis Consider chest x-ray, blo Annex 2 Management of Bronchiolitis in General Practice DIAGNOSIS h: Consider alternate diagnoses in a child who presents with: al signs and symptoms of an upper respiratory tract infection • Recurrent wheezing h • Cough as the predominant ypnoea • Persistent, or repeated a iratory crepitations • Failure to thrive eze • Cardiac murmur, oedema rologic tests should NOT be used to diagnose bronchiolitis. • Sudden onset of symptom wheeze, loss of voice, or differential air entry Trial Of Bronchodilator Therapy A child with bronchiolitis-like symptoms who responds to treatment with a bronchodilator is likely to have asthma. Consider a trial of a single dose of β2 agonist bronchodilators in patients older than 9 months, particularly with recurrent wheezing. ASSESSMENT OF SEVERITY OF DISEASE* Moderate mal Severe Increased • Markedly • respiratory rate increased respiratory rate • • re r Minor • Moderate/marked • accessory muscle use accessory muscle use • M • Nasal flare • and/or grunting mal Increased • heart rate to Markedly • increased heart rate Difficulty • feeding Unable to feed • Marked • Minor • dehydration dehydration Crepitations • gen • saturation 90-95%* Oxygen • Toxic appearance • Sweaty • Irritable • saturation <90%* Oxygen <36 weeks gestation, and those who have underlying cardiorespiratory disease as they have an increased risk of more severe disease and apnoea. Consider virolo INITIAL TREATMENT Send to • SEND TO HOSPITAL BY AMBULANCE hospital if requiring oxygen Consider • sending to hospital if not tolerating oral feeds • urage Consider oxygen if child is <3 months old, has increased work of breathing, decreased oxygenation during feeds or saturation 9092% • Provide oxygen oxy Encourage • small frequent feeds asal If nasal • congestion, trial saline nasal drops Annexes • 78 Southern Health Clinical Practice Guideline for the Management of Bronchiolitis in Infants and Children de Provide • • patient information, including reasons to return nge Arrange • review in next 2 days d Stay with the • Send written • patient until the ambulance arrives • wit assessment and referral details wr Send home • if stable *N.B. If patient has signs or symptoms across categories, always treat according to their most severe features. ndicator of severity however it is recognised that this form of assessment will not be available to most GPs. Treatment should not be based on a child’s Annexes 79 Southern Health Clinical Practice Guideline for the Management of Bronchiolitis in Infants and Children Annex 3 Normal Parameters for Paediatric Vital Signs Neonate Heart Rate (awake) Toddler (2 yrs) Preschool School-age (7 yrs) Adolescent (15yrs) 100-180 Infant (6 months) 100-160 80-150 70-110 65-110 60-90 80-160 80-160 70-120 60-90 60-90 50-90 30-80 30-60 24-40 22-34 18-30 12-20 60-90 87-105 95-105 95-110 97-112 112-128 20-60 50-66 50-66 50-78 57-80 66-80 36.5-37.5 36.5-37.5 36.0-37.2 36.0-37.2 36.0-37.2 36.0-37.2 (beats/min) Heart Rate (asleep) (beats/min) Respiratory Rate (breaths/min) Systolic BP (5-95%) (mmHg) Diastolic BP (5-95%) (mmHg) Temperature (oC) Annexes 80 Southern Health Clinical Practice Guideline for the Management of Bronchiolitis in Infants and Children Glossary Child Infant Person aged between 12 months and 19 years Person aged 12 months or less Acronyms and Abbreviations 95%CI ABG ALRI BPD CBC CLD EIA GDG HR ICU IFA IQR LOS NPA PCR RDAI RR RSV RSVIG Glossary 95% confidence interval Arterial blood gas Acute lower respiratory infection Bronchopulmonary dysplasia Complete blood count Chronic lung disease Enzyme immuno-assays Guideline development group Heart rate Intensive care unit Immunofluorescence assay Interquartile range Length of stay Nasopharyngeal aspirate Polymerase chain reaction Respiratory Distress Assessment Instrument Respiratory rate Respiratory syncytial virus Respiratory syncytial virus immunoglobulin 81
© Copyright 2024