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

• Status: Completed
• Trial end date: 2006-04-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Hospital for Sick Children
• Collaborator: The Physicians' Services Incorporated Foundation
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

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