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

This study has been completed.
The Physicians' Services Incorporated Foundation
Information provided by (Responsible Party):
Suzanne Schuh, The Hospital for Sick Children Identifier:
First received: September 13, 2005
Last updated: May 12, 2014
Last verified: May 2014

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
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)

Ages Eligible for Study:   2 Months to 24 Months
Genders Eligible for Study:   Both
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
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Please refer to this study by its identifier: NCT00213226

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

Responsible Party: Suzanne Schuh, Staff Physician, The Hospital for Sick Children Identifier: NCT00213226     History of Changes
Other Study ID Numbers: 0020010349
Study First Received: September 13, 2005
Last Updated: May 12, 2014
Health Authority: Canada: Health Canada

Keywords provided by The Hospital for Sick Children:

Additional relevant MeSH terms:
Bronchial Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Tract Diseases
Respiratory Tract Infections
BB 1101
Dexamethasone 21-phosphate
Dexamethasone acetate
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors
Therapeutic Uses processed this record on November 20, 2014