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

This study has been completed.
Sponsor:
Collaborator:
The Physicians' Services Incorporated Foundation
Information provided by:
The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT00213226
First received: September 13, 2005
Last updated: April 12, 2010
Last verified: April 2010
  Purpose

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 Intervention Phase
Bronchiolitis
Drug: dexamethasone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Efficacy of Single Dose Versus Multiple Doses of Dexamethasone in Outpatients With Acute Bronchiolitis

Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • 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:
  • 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

Estimated Enrollment: 120
Study Start Date: December 2001
Study Completion Date: April 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   2 Months to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00213226

Locations
Canada, Ontario
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
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00213226     History of Changes
Other Study ID Numbers: 0020010349
Study First Received: September 13, 2005
Last Updated: April 12, 2010
Health Authority: Canada: Health Canada

Keywords provided by The Hospital for Sick Children:
bronchiolitis
pediatrics
corticosteroids

Additional relevant MeSH terms:
Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 23, 2014