Bronchiolitis in Infants Placebo Versus Epinephrine and Dexamethasone Study
Status:
Recruiting
Trial end date:
2023-10-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 3
Details
Lead Sponsor:
Children's Hospital of Eastern Ontario
Collaborators:
Alberta Children's Hospital Research Institute Canadian Institutes of Health Research (CIHR) Children's Hospital Research Institute of Manitoba Department of Pediatrics, Western University Research Manitoba St. Justine's Hospital The Hospital for Sick Children Women and Children's Health Research Institute, University of Alberta