Status:
COMPLETED
Single Dose Versus Multiple Doses of Dexamethasone in Children With Acute Bronchiolitis
Lead Sponsor:
The Hospital for Sick Children
Collaborating Sponsors:
The Physicians' Services Incorporated Foundation
Conditions:
Bronchiolitis
Eligibility:
All Genders
2-24 years
Phase:
PHASE3
Brief Summary
This study is to determine the effectiveness of five-day treatment versus a single dose of oral dexamethasone (corticosteroid) in children between 2 and 24 months of age with a first episode of acute ...
Eligibility Criteria
Inclusion
- infants 2 to 24 months of age
- acute bronchiolitis, defined as first episode of wheezing with upper respiratory infection and respiratory distress
- moderate to severe baseline disease severity (Respiratory Distress Index (RDAI) score 6 to 15)
- only patients discharged at or shortly after 240 minutes of uniform stabilization therapy will be randomized
Exclusion
- previous wheezing and/or bronchodilator therapy
- hospitalization at 240 minutes
- critically ill patients needing airway stabilization
- patients with low or very high baseline disease severity (RDAI \<5 and \>16)
- patients under 8 weeks of age
- patients on corticosteroids prior to arrival at Emergency Department
- contact with varicella within 21 days
- past history of ventilation for greater than 24 hours
- existing cardiopulmonary disease, multisystem disease or immunodeficiency
- insufficient command of the English language
Key Trial Info
Start Date :
December 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2006
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00213226
Start Date
December 1 2001
End Date
April 1 2006
Last Update
May 13 2014
Active Locations (1)
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1
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8