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

OVERVIEW

Status: Recruiting
ClinicalTrials.Gov Identifier: NCT03567473
Principal Investigator: Dr. Amy Plint
Project Manager: Natasha Wills-Ibarra

POPULATION

We will enroll 1,616 infants across Canada, New Zealand, and Australia 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.

OBJECTIVES

Primary Objective:

  1. 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 post enrolment 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 admissions to hospital (for bronchiolitis) at enrolment ED visit compared to placebo.

  2. To determine if there is a difference between groups in all cause admission within 21 days post enrolment, all cause health care provider visits over 21 days post enrolment, and health care-related costs.

PARTICIPATING SITES

This study will enroll patients at six pediatric academic EDs across Canada.

Participating Canadian sites are: 
CHU Ste. Justine (Montreal), Children’s Hospital of Eastern Ontario (Ottawa), Children’s Hospital – London Health Sciences Centre (London), Health Sciences Centre Winnipeg Children’s Hospital (Winnipeg), Alberta Children’s Hospital (Calgary), and Stollery Children’s Hospital (Edmonton). 

This study will also enroll patients at academic pediatric EDs and community EDs in New Zealand and Australia.
In New Zealand, the following hospitals will participate:
Starship Children’s Hospital, Auckland; Kidz First Hospital, Auckland; Waikato Hospital, Hamilton.
In Australia, the following hospitals will participate:
Women and Children’s Hospital, Adelaide, South Australia; Monash Medical Centre, Melbourne, VIC; Perth Children’s Hospital, Perth, WA.