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Oral Dexamethasone for Bronchiolitis: A randomized Trial Journal club 20/2/14 Alansari K et al. Oral dexamethasone for bronchiolitis: a randomised trial. Pediatrics 2013 Oct;132(4):e810-6.
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Population Qatar 2010- 2012 (bronchiolitis seasons) Infants ≤ 18 months “moderate to severe” bronchiolitis (Wang score ≥ 4) Bronchiolitis defined as viral URTI followed by wheezing or crackles on auscultation Hx of eczema or 1 st degree relative with asthma Exclusions:- any previous wheeze, 02 sats ≤85%
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Methods Assess on the acute ward CXR & NPA for every patient Randomise (concealed envelopes)
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Intervention 1mg/kg dexamethasone for one day Then 0.6mg/kg per day for 4 days Or placebo
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“Standard” Care Salbutamol Nebs at 0, 30, 60, 120 minutes then every 2 hours throughout admission Nebulsied Epinephrine 2.5- 5ml, if needed up to hourly
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Primary Outcome Time from randomisation to ready for discharge as deemed fit by Dr on call (all patients get 6hrly review) - Decided does not need O2, ? Sats ≥ 94%- Feeding adequately - Minimal or absent wheezing, crackles or chest recessions
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Secondary Outcomes Need for epinephrine Re-admission rates
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CASP
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Are the results valid? 1.Did the trial address a clearly focused issue? Yes
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Are the results valid? 2.Was the assignment of patients to treatments randomised? Yes
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Are the results valid? 3.Were all the patients who entered the trial accounted for at its conclusion?
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Is it worth continuing? 4.Were patients, health workers and study personel “blind” to the treatment? Yes
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5.Were the groups similar at the start of the trial?
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6.Aside from the intervention, were the groups treated equally? ?Yes
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What are the results?
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Will the results help locally?? 9.Can the results be applied in your context? No Not our standard care Not our definition of bronchiolitis Not same Dr levels/ review rates Primary outcome definition unclear
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10.Were all clinically important outcomes considered? ?Yes
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11.Are the benefits worth the harms and costs? Yes
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The frustrations of a bronchiolitis trial
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Bronchiolitis Research Many studies/ meta analyses Many definitions of bronchiolitis Many age ranges Many populations Many confounding factors Many outcomes (scores/ length of treatment/ length of stay
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Definitions of Bronchiolitis UK “a seasonal viral illness characterised by fever, nasal discharge, dry, wheezy cough”. On examination there are fine inspiratory crackles and/ or high pitched expiratory wheeze Infants under 1 year of age
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USA “a constellation of of clinical symptoms and signs including a viral upper respiratory prodrome followed by increased respiratory effort and wheezing in children less than 2 years”
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Diagnosis Clinical ?NPA ?CXR
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Schuh et al, 2007 (J Pediatr) 265 infants with simple bronchiolitis, all had CXR Only 2 CXRs not consistent with bronchiolitis (& neither case changed management) More likely to treat with abx after reviewing CXRs (although not indicated)
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Management
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Aetiology Viral upper -> Lower respiratory infection Bronchiolar epithelial inflammation Peribronchial infiltration of WBCs Submucosal oedema Airway narrowing through oedema and blockage with mucus (not smoothe muscle constriction)
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Wheeze
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Bronchodilators
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8 trials, 468 infants No improvement in score in 43% treated with bronchodilators (57% in controls) Modest, short term effect in scores No change in other clinical measures (eg oxygenation) Authors conclude bronchodilators not recommended
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Authors’ Conclusions Insufficient evidence to support use for inpatients. Possibly some benefit as outpatients Variety of definitions, outcomes and patient groups
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Inflammation
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Corticosteroids Howard M et al, 2007 600 infants 2-12 months Randomised to dex or placebo No difference in scores, admission rates, clinical outcomes
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? Benefit combined? Hartling et al 2011 Controversial meta- analysis Accused of selection bias Included children up to 2 yrs
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Airway Oedema
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Hypertonic saline Zhang et al, 2013 Hypertonic vs 0.9% saline Infants <2 years Conclude that length of stay reduced by hypertonic saline But many confounding factors in studies analysed
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SABRE: Hypertonic Saline in Acute Bronchiolitis: A Randomised Controlled Trial and Economic Evaluation
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