A Randomized Controlled Trial Comparing Epinephrine and Dexamethasone to Placebo in the Treatment of Infants with Bronchiolitis

 
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OVERVIEW

Status: recruiting
ClinicalTrials.gov Identifier:NCT03567473
Principal Investigator: Dr. Amy Plint (CHEO)
Project Manager: Tremaine Rowe


 

Objectives

Primary Objective: To determine if treatment of infants presenting with bronchiolitis to the emergency department (ED) with nebulized epinephrine and a 2-day course of oral dexamethasone is effective in reducing the need for hospitalization (due to bronchiolitis) by day 7 compared to placebo.

Secondary Objectives:

(1)   To determine if treatment of infants presenting with bronchiolitis to the ED with nebulized epinephrine and a 2-day course of oral dexamethasone is effective in reducing hospitalizations (for bronchiolitis) at enrolment ED visit and/or by day 21 compared to placebo.

(2)   To determine if there is a difference between groups in all cause hospitalizations by day 7, all cause hospitalizations by day 21, all cause ED visits over 21 days, length of ED visit, length of hospitalization, length of symptoms, and health care-related costs.

Population

We will enroll 1800 infants across Canada at participating sites. We will enroll children > 60 days of age and < 12 months of age presenting with bronchiolitis during the winter viral season. Children born at less than 37-weeks gestation and less than 60 days  corrected age and those with known chronic lung disease,  congenital heart disease, immunodeficiency, recent exposure to varicella, and those who are critically unwell will not be enrolled in the study.

 

Inclusion Criteria

 TBA

 

Exclusion Criteria

TBA