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