Bronchiolitis in Infants Placebo Versus Epinephrine and Dexamethasone Study

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.

Timeline

Start

2018-12-13

Primary completion

2025-01-07

Completion

2025-05-21

Publications

• Heath A, Rios D, Vogel KI, Rowe T, Wills-Ibarra N, Oakley E, Offringa M, Pechlivanoglou P, Klassen TP, Dalziel SR, Plint AC; KidsCan Pediatric Emergency Research Canada (PERC) Innovative Pediatric Clinical Trials and Pediatric Research in Emergency Department International Collaborative (PREDICT) BIPED Study Team. A randomised controlled trial comparing epinephrine and dexamethasone to placebo in the treatment of infants with bronchiolitis (BIPED study): a statistical analysis plan. Trials. 2025 Nov 12;26(1):496. doi: 10.1186/s13063-025-09125-w.
• Lan J, Plint AC, Dalziel SR, Klassen TP, Offringa M, Heath A; Pediatric Emergency Research Canada (PERC) KIDSCAN/PREDICT BIPED Study Group. Remote, real-time expert elicitation to determine the prior probability distribution for Bayesian sample size determination in international randomised controlled trials: Bronchiolitis in Infants Placebo Versus Epinephrine and Dexamethasone (BIPED) study. Trials. 2022 Apr 11;23(1):279. doi: 10.1186/s13063-022-06240-w.

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