Condition category
Respiratory
Date applied
26/09/2005
Date assigned
26/09/2005
Last edited
15/05/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Amy Catherine Plint

ORCID ID

Contact details

Children's Hospital of Eastern Ontario
401 Smyth Road
Ottawa
K1H 8L1
Canada
+1 8 737 7600 ext. 3237
plint@cheo.on.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MCT-67276

Study information

Scientific title

A randomised controlled trial of nebulised epinephrine and oral dexamethasone in the treatment of outpatients with bronchiolitis

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

Children's Hospital of Easter Ontario Research Ethics Board gave approval in May 2004.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Bronchiolitis

Intervention

1. Oral dexamethasone
2. Nebulised epinephrine

Trial details received: 12 Sept 2005

Intervention type

Drug

Phase

Not Applicable

Drug names

Dexamethasone, epinephrine

Primary outcome measures

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 trial start date

01/04/2004

Overall trial end date

31/03/2008

Reason abandoned

Eligibility

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 type

Patient

Age group

Child

Gender

Both

Target number of participants

800

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

Locations

Countries of recruitment

Canada

Trial participating centre

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

Sponsor information

Organisation

Children's Hospital of Eastern Ontario (Canada)

Sponsor details

401 Smyth Road
Ottawa
K1H 8L1
Canada
+1 8 737 7600
webmaster@cheo.on.ca

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Research organisation

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19439742

Publication citations

  1. Results

    Plint AC, Johnson DW, Patel H, Wiebe N, Correll R, Brant R, Mitton C, Gouin S, Bhatt M, Joubert G, Black KJ, Turner T, Whitehouse S, Klassen TP, , Epinephrine and dexamethasone in children with bronchiolitis., N. Engl. J. Med., 2009, 360, 20, 2079-2089, doi: 10.1056/NEJMoa0900544.

Additional files

Editorial Notes