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ISRCTN
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ISRCTN56745572
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ClinicalTrials.gov identifier
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Public title
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Canadian Bronchiolitis Epinephrine Steroid Trial
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Scientific title
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A randomised controlled trial of nebulised epinephrine and oral dexamethasone in the treatment of outpatients with bronchiolitis
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Acronym
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CanBEST
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Serial number at source
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MCT-67276
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Study hypothesis
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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.
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Lay summary
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Ethics approval
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Children's Hospital of Easter Ontario Research Ethics Board gave approval in May 2004.
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Study design
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Randomised controlled trial
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Countries of recruitment
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Canada
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Disease/condition/study domain
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Bronchiolitis
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/04/2004
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Anticipated end date
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31/03/2008
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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800
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Interventions
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1. Oral dexamethasone
2. Nebulised epinephrine
Trial details received: 12 Sept 2005
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Primary outcome measure(s)
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Admission to hospital up to 7 days after enrolment
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Secondary outcome measure(s)
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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
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Sources of funding
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Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-67276)
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Trial website
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Publications
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2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19439742
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Contact name
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Dr
Amy Catherine
Plint
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Address
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Children's Hospital of Eastern Ontario
401 Smyth Road
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City/town
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Ottawa
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Zip/Postcode
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K1H 8L1
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Country
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Canada
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Tel
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+1 8 737 7600 ext. 3237
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Fax
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+1 8 738 4852
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Email
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plint@cheo.on.ca
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Sponsor
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Children's Hospital of Eastern Ontario (Canada)
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Address
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401 Smyth Road
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City/town
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Ottawa
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Zip/Postcode
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K1H 8L1
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Country
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Canada
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Tel
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+1 8 737 7600
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Fax
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+1 8 738 4801
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Email
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webmaster@cheo.on.ca
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Date applied
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26/09/2005
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Last edited
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15/05/2009
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Date ISRCTN assigned
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26/09/2005
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