Canadian Bronchiolitis Epinephrine Steroid Trial

ISRCTN	ISRCTN56745572
DOI	https://doi.org/10.1186/ISRCTN56745572
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	MCT-67276
Sponsor	Children's Hospital of Eastern Ontario (Canada)
Funder	Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-67276)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Amy Catherine Plint
Scientific

Children's Hospital of Eastern Ontario
401 Smyth Road
Ottawa
K1H 8L1
Canada

Phone	+1 8 737 7600 ext. 3237
Email	plint@cheo.on.ca

Primary study design	Interventional
Study design	Randomized controlled trial
Secondary study design	Randomised controlled trial
Scientific title	A randomised controlled trial of nebulised epinephrine and oral dexamethasone in the treatment of outpatients with bronchiolitis
Study acronym	CanBEST
Study objectives	We hypothesise that children presenting to the Emergency Department (ED) with bronchiolitis and who are treated with nebulised epinephrine and/or oral dexamethasone will have fewer hospitalisations and a shorter, less severe illness.
Ethics approval(s)	Children's Hospital of Easter Ontario Research Ethics Board gave approval in May 2004.
Health condition(s) or problem(s) studied	Bronchiolitis
Intervention	1. Oral dexamethasone 2. Nebulised epinephrine Trial details received: 12 Sept 2005
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Dexamethasone, epinephrine
Primary outcome measure(s)	Admission to hospital up to 7 days after enrolment
Key secondary outcome measure(s)	1. Time to discharge 2. Length and severity of symptoms 3. Change in RDAI 4. Economic costs 5. Change in oxygen saturation from baseline at times 60, 120, 180 and 240 minutes 6. Co-interventions 7. Return to be evaluated by health care provider for on-going symptoms related to bronchiolitis 8. Adverse events
Completion date	31/03/2008

Participant type(s)	Patient
Age group	Child
Lower age limit	6 Weeks
Upper age limit	12 Months
Sex	All
Target sample size at registration	800
Total final enrolment	800
Key inclusion criteria	1. Age 6 weeks to 12 months, either sex 2. Respiratory distress assessment instrument (RDAI) score of greater than 3 and less than 15 3. Diagnosis of bronchiolitis
Key exclusion criteria	1. Asthma or any previous episode of wheezing treated with bronchodilators 2. Chronic cardiopulmonary disease 3. Presence of varicella or recent close contact 4. Severe respiratory distress 5. Recent treatment with oral or inhaled steroids 6. Insurmountable language barrier 7. Any child born at less than 37 weeks gestation who is less than 6 weeks corrected age
Date of first enrolment	01/04/2004
Date of final enrolment	31/03/2008

Children's Hospital of Eastern Ontario

Ottawa
K1H 8L1
Canada

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	14/05/2009		Yes	No
Results article		16/05/2025	19/05/2025	Yes	No

19/05/2025: Publication reference and total final enrolment added.