Bronchiolitis in Infants Placebo Versus Epinephrine and Dexamethasone Study

PHASE3CompletedINTERVENTIONAL
Enrollment

864

Participants

Timeline

Start Date

December 13, 2018

Primary Completion Date

January 7, 2025

Study Completion Date

May 21, 2025

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.

Trial Locations (12)

1142

Starship Children's Hospital, Auckland

2025

Kidz First Hospital, Auckland

3168

Monash Medical Centre, Melbourne

3240

Waikato Hospital, Hamilton

5006

Women and Children's Hospital, Adelaide

6008

Perth Children's Hospital, Perth

T3B 6A9

Children's Hospital of Alberta, Calgary

T6G 2C8

Stollery Children's Hospital, Edmonton

N6A 5W9

Childrens Hospital at London Health Sciences, London

K1H 8L1

Children's Hospital of Eastern Ontario, Ottawa

HT3 1C5

CHU Sainte-Justines Hospital, Montreal

R3A 1S1

Children's Hospital of Winnipeg, Sherbrook

All Listed Sponsors
collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

collaborator

Children's Hospital Research Institute of Manitoba

OTHER

collaborator

Research Manitoba

OTHER

collaborator

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

UNKNOWN

collaborator

Alberta Children's Hospital Research Institute

OTHER

collaborator

The Hospital for Sick Children

OTHER

collaborator

Department of Pediatrics, Western University

UNKNOWN

collaborator

St. Justine's Hospital

OTHER

lead

Children's Hospital of Eastern Ontario

OTHER

NCT03567473 - Bronchiolitis in Infants Placebo Versus Epinephrine and Dexamethasone Study | Biotech Hunter | Biotech Hunter