Canadian Bronchiolitis Epinephrine Steroid Trial

ISRCTN	ISRCTN56745572
DOI	https://doi.org/10.1186/ISRCTN56745572
Secondary identifying numbers	MCT-67276

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

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

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	A randomised controlled trial of nebulised epinephrine and oral dexamethasone in the treatment of outpatients with bronchiolitis
Study acronym	CanBEST
Study hypothesis	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.
Condition	Bronchiolitis
Intervention	1. Oral dexamethasone 2. Nebulised epinephrine Trial details received: 12 Sept 2005
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Dexamethasone, epinephrine
Primary outcome measure	Admission to hospital up to 7 days after enrolment
Secondary outcome measures	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
Overall study start date	01/04/2004
Overall study end date	31/03/2008

Participant type(s)	Patient
Age group	Child
Lower age limit	6 Weeks
Upper age limit	12 Months
Sex	Both
Target number of participants	800
Participant 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
Participant 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
Recruitment start date	01/04/2004
Recruitment end date	31/03/2008

Children's Hospital of Eastern Ontario

Ottawa
K1H 8L1
Canada

Children's Hospital of Eastern Ontario (Canada)
Hospital/treatment centre

401 Smyth Road
Ottawa
K1H 8L1
Canada

Research organisation

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-67276)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	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