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

Bronchiolitis Clinical Trial

Official title:

Efficacy of Single Dose Versus Multiple Doses of Dexamethasone in Outpatients With Acute Bronchiolitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00213226
• Other study ID #: 0020010349
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: May 12, 2014
• Start date: December 2001
• Est. completion date: April 2006

Study information

• Verified date: May 2014
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 2006
• Est. primary completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Months to 24 Months

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bronchiolitis

Intervention

Drug:
• dexamethasone

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
The Hospital for Sick Children	The Physicians' Services Incorporated Foundation

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Respiratory Assessment Change Score (RACS) at 96 and 144 hours
Secondary	Proportion of infants with unscheduled medical visits for respiratory distress within the 6 day study period
Secondary	Proportion of infants with no signs of respiratory distress at 96 and 144 hours
Secondary	Proportion of infants who are symptomatic at 14 days