Oral Dexamethasone for Bronchiolitis: A randomized TrialJournal club 20/2/14
Alansari K et al. Oral dexamethasone for bronchiolitis: a randomised trial. Pediatrics 2013 Oct;132(4):e810-6.
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 1st degree relative with asthma• Exclusions:- any previous wheeze, 02 sats ≤85%
Methods• Assess on the acute ward• CXR & NPA for every patient• Randomise (concealed envelopes)
Intervention• 1mg/kg dexamethasone for one day• Then 0.6mg/kg per day for 4 days• Or placebo
“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
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
Secondary Outcomes• Need for epinephrine• Re-admission rates
CASP
Are the results valid?1. Did the trial address a clearly focused issue?
Yes
Are the results valid?2. Was the assignment of patients to treatments randomised?
Yes
Are the results valid?3. Were all the patients who entered the trial
accounted for at its conclusion?
Is it worth continuing?4. Were patients, health workers and study personel “blind” to the treatment?
Yes
5. Were the groups similar at the start of the trial?
6. Aside from the intervention, were the groups treated equally?
?Yes
What are the results?
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
10. Were all clinically important outcomes considered?
?Yes
11. Are the benefits worth the harms and costs?
Yes
The frustrations of a bronchiolitis trial
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
Definitions of BronchiolitisUK
• “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
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”
Diagnosis• Clinical• ?NPA• ?CXR
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)
Management
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)
Wheeze
Bronchodilators
Bronchodilators• 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
Authors’ Conclusions• Insufficient evidence to support use for inpatients.• Possibly some benefit as outpatients• Variety of definitions, outcomes and patient groups
Inflammation
Corticosteroids• Howard M et al, 2007• 600 infants 2-12 months• Randomised to dex or
placebo• No difference in scores,
admission rates, clinical outcomes
? Benefit combined?
• Hartling et al 2011• Controversial meta-
analysis• Accused of selection bias• Included children up to 2
yrs
Airway Oedema
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
SABRE: Hypertonic Saline in Acute Bronchiolitis: A Randomised Controlled Trial and Economic Evaluation