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

NCT00213226 | Completed Phase 3

• 1 other identifier: 0020010349
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Bronchiolitis

Keywords

bronchiolitis; pediatrics; corticosteroids

Outcome Measures

Primary Outcomes (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 Outcomes (4)

• 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

Interventions

dexamethasone DRUG

Eligibility Criteria

• Age: 2 Months - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• The Physicians' Services Incorporated Foundation: collaborator

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related 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.

  PMID: 18668692 RESULT

MeSH Terms

Conditions

Bronchiolitis

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Suzanne Schuh, MD

  The Hospital for Sick Children, Toronto, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: December 1, 2001
• Primary Completion: April 1, 2006
• Study Completion: April 1, 2006
• Last Updated: May 13, 2014

Record last verified: 2014-05

Locations

CA (1)