Single Dose Versus Multiple Doses of Dexamethasone in Children With Acute Bronchiolitis

Phase 3

Completed

• Conditions: Bronchiolitis

• Registration Number: NCT00213226
• Lead Sponsor: The Hospital for Sick Children

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

Detailed Description

Not available

Study Timeline

• Study Start: 2001-12
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Primary Completion: 2006-04
• Study Completion: 2006-04
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-12
• Last Update Posted: 2014-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada