We hypothesize that infants with bronchiolitis treated with inhaled epinephrine in the Emergency Department (ED) and a 2-day course of oral dexamethasone will have fewer hospitalizations over 7 days compared to infants treated with placebo. To examine this hypothesis, we will conduct a phase III, multicentre, randomized, double-blind trial. Infants presenting to one of twelve study EDs will be enrolled to one of two study groups: (1) inhaled epinephrine and oral dexamethasone or (2) inhaled placebo and oral placebo. Our primary outcome will be admission for bronchiolitis by day 7 following the enrolment. As a planned secondary analysis, a between-group comparison of the primary outcome will be performed in those patients presenting with a first episode of bronchiolitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
864
Two doses of oral dexamethasone, 0.6 mg/kg (maximum single dose 10 mg). One at the time of emergency department enrolment immediately prior to first nebulized treatment and one at approximately 24 hour later
Two nebulized treatments of 3 mL 1:1000 epinephrine 30 minutes apart (+/- 15 minutes) at the time of emergency department enrolment
Two doses of oral placebo, 0.6 mL/kg (maximum single dose 10 mL). One at the time of emergency department enrolment immediately prior to nebulized treatment and one at approximately 24 hour later . Oral placebo at Canadian sites is composed of OraBlendTM and in New Zealand and Australian sites will be a compounded solution.
Two nebulized treatments of 3 mL of normal saline 30 minutes apart (+/- 15 minutes) at the time of emergency department enrolment
Two doses of Epinephrine given by MDI plus spacer at 625 mcg (5 actuations of 125mcg) 30 minutes apart (+/- 15 minutes) at the time of emergency department enrolment.
Two doses of inhaled placebo given by MDI plus spacer, 30 minutes apart (+/- 15 minutes) at the time of emergency department enrolment.
Women and Children's Hospital
Adelaide, Australia
Monash Medical Centre
Melbourne, Australia
Perth Children's Hospital
Perth, Australia
Children's Hospital of Alberta
Calgary, Alberta, Canada
Stollery Children's Hospital
Edmonton, Alberta, Canada
Childrens Hospital at London Health Sciences
London, Ontario, Canada
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada
CHU Sainte-Justines Hospital
Montreal, Quebec, Canada
Children's Hospital of Winnipeg
Sherbrook, Winnipeg, Canada
Starship Children's Hospital
Auckland, New Zealand
...and 2 more locations
Admission to hospital for bronchiolitis within 7 days post enrollment
1\) patient being admitted to inpatient ward, or 2) an ED length of stay 12 hours or greater or 3) a combined ED and observation unit stay of 12 hours or greater.
Time frame: 7 days post enrollment
Admission to hospital for bronchiolitis at the time of the enrollment ED visit
1\) patient being admitted to inpatient ward, or 2) an ED length of stay 12 hours or greater or 3) a combined ED and observation unit stay of 12 hours or greater.
Time frame: Enrollment visit
All cause admission to Hospital within 21 days following enrollment ED visit
1\) patient being admitted to inpatient ward, or 2) an ED length of stay 12 hours or greater or 3) a combined ED and observation unit stay of 12 hours or greater.
Time frame: up to 21 days post enrollment
All cause Health care provider visits (including ED visits) by day 21 following enrollment ED
Visits to ED, other clinic, primary care provider, or any visit to see a nurse or physician following enrollment
Time frame: up to 21 days post enrollment
Health Care related costs within the 21 days following enrollment ED visits.
Health care related costs
Time frame: up to 21 days post enrollment
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