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

• Sponsor: The Hospital for Sick Children (Other)
• Overall Status: Completed
• CT.gov ID: NCT00213226
• Collaborator: The Physicians' Services Incorporated Foundation (Other)
• Enrollment: 120
• Location: 1
• Duration (Months): 52
• Patients Per Site Per Month: 2.3

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Bronchiolitis	Drug: dexamethasone	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: Efficacy of Single Dose Versus Multiple Doses of Dexamethasone in Outpatients With Acute Bronchiolitis
• Study Start Date: Dec 1, 2001
• Actual Primary Completion Date: Apr 1, 2006
• Actual Study Completion Date: Apr 1, 2006

Outcome Measures

Primary Outcome Measures

1. 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

1. Respiratory Assessment Change Score (RACS) at 96 and 144 hours []

2. Proportion of infants with unscheduled medical visits for respiratory distress within the 6 day study period []

3. Proportion of infants with no signs of respiratory distress at 96 and 144 hours []

4. Proportion of infants who are symptomatic at 14 days []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Months to 24 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Hospital for Sick Children	Toronto	Ontario	Canada	M5G 1X8

Sponsors and Collaborators

• The Hospital for Sick Children
• The Physicians' Services Incorporated Foundation

Investigators

• Principal Investigator: Suzanne Schuh, MD, The Hospital for Sick Children, Toronto, Canada

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Suzanne Schuh, Staff Physician, The Hospital for Sick Children
• ClinicalTrials.gov Identifier: NCT00213226
• Other Study ID Numbers: 0020010349
• First Posted: Sep 21, 2005
• Last Update Posted: May 13, 2014
• Last Verified: May 1, 2014

• Keywords provided by Suzanne Schuh, Staff Physician, The Hospital for Sick Children: bronchiolitis; pediatrics; corticosteroids
• Additional relevant MeSH terms: Bronchiolitis; Dexamethasone

Study Results

No Results Posted as of May 13, 2014