Transcript Department Presentation Title - Sheffield Children's Hospital

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.
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
Yes
issue?
Are the results valid?
2.
Was the assignment of patients to
randomised?
Yes
treatments
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
treated equally?
?Yes
groups
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
Yes
costs?
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 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
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 metaanalysis
• 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