Back to resultsSingle Dose Versus Multiple Doses of Dexamethasone in Children With Acute Bronchiolitis
Primary Purpose
Bronchiolitis
Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
dexamethasone
Sponsored by
About this trial
This is an interventional treatment trial for Bronchiolitis focused on measuring bronchiolitis, pediatrics, corticosteroids
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Sites / Locations
- The Hospital for Sick Children
Outcomes
Primary Outcome Measures
Proportion of patients stabilized, discharged and subsequently hospitalized and/or co-interventions with corticosteroids or beta2 agonists outside the protocol within the 6 day study period
Secondary Outcome Measures
Respiratory Assessment Change Score (RACS) at 96 and 144 hours
Proportion of infants with unscheduled medical visits for respiratory distress within the 6 day study period
Proportion of infants with no signs of respiratory distress at 96 and 144 hours
Proportion of infants who are symptomatic at 14 days
Full Information
NCT ID
NCT00213226
First Posted
September 13, 2005
Last Updated
May 12, 2014
Sponsor
The Hospital for Sick Children
Collaborators
The Physicians' Services Incorporated Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00213226
Brief Title
Single Dose Versus Multiple Doses of Dexamethasone in Children With Acute Bronchiolitis
Official Title
Efficacy of Single Dose Versus Multiple Doses of Dexamethasone in Outpatients With Acute Bronchiolitis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
December 2001 (undefined)
Primary Completion Date
April 2006 (Actual)
Study Completion Date
April 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children
Collaborators
The Physicians' Services Incorporated Foundation
4. Oversight
5. Study Description
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 bronchiolitis presenting in the Emergency Department
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis
Keywords
bronchiolitis, pediatrics, corticosteroids
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
dexamethasone
Primary Outcome Measure Information:
Title
Proportion of patients stabilized, discharged and subsequently hospitalized and/or co-interventions with corticosteroids or beta2 agonists outside the protocol within the 6 day study period
Secondary Outcome Measure Information:
Title
Respiratory Assessment Change Score (RACS) at 96 and 144 hours
Title
Proportion of infants with unscheduled medical visits for respiratory distress within the 6 day study period
Title
Proportion of infants with no signs of respiratory distress at 96 and 144 hours
Title
Proportion of infants who are symptomatic at 14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzanne Schuh, MD
Organizational Affiliation
The Hospital for Sick Children, Toronto, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
18668692
Citation
Schuh S, Coates AL, Dick P, Stephens D, Lalani A, Nicota E, Mokanski M, Khaikin S, Allen U. A single versus multiple doses of dexamethasone in infants wheezing for the first time. Pediatr Pulmonol. 2008 Sep;43(9):844-50. doi: 10.1002/ppul.20845.
Results Reference
result
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Single Dose Versus Multiple Doses of Dexamethasone in Children With Acute Bronchiolitis
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