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.

Conditions

• Bronchiolitis

Interventions

DRUG

Oral dexamethasone

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

DRUG

Nebulized Epinephrine

Two nebulized treatments of 3 mL 1:1000 epinephrine 30 minutes apart (+/- 15 minutes) at the time of emergency department enrolment

DRUG

Oral placebo

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.

DRUG

Nebulized normal saline

Two nebulized treatments of 3 mL of normal saline 30 minutes apart (+/- 15 minutes) at the time of emergency department enrolment

DRUG

MDI Epinephrine

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.

DRUG

MDI placebo

Two doses of inhaled placebo given by MDI plus spacer, 30 minutes apart (+/- 15 minutes) at the time of emergency department enrolment.

Sponsors & Collaborators

• Canadian Institutes of Health Research (CIHR)

  collaborator OTHER_GOV

• Children's Hospital Research Institute of Manitoba

  collaborator OTHER

• Research Manitoba

  collaborator OTHER

• Women and Children's Health Research Institute, University of Alberta

  collaborator UNKNOWN

• Alberta Children's Hospital Research Institute

  collaborator OTHER

• The Hospital for Sick Children

  collaborator OTHER

• Department of Pediatrics, Western University

  collaborator UNKNOWN

• St. Justine's Hospital

  collaborator OTHER

• Children's Hospital of Eastern Ontario

  lead OTHER

Principal Investigators

• Amy Plint, MSc, MD · Childrens Hospital of Eastern Ontario (CHEO)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

60 Days

Max Age

12 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-12-13

Primary Completion

2025-01-07

Completion

2025-05-21

Countries

• Australia
• Canada
• New Zealand

Study Locations