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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00213226
First Posted: September 21, 2005
Last Update Posted: May 13, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
The Physicians' Services Incorporated Foundation
Information provided by (Responsible Party):
Suzanne Schuh, The Hospital for Sick Children
  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
Intervention Model: Parallel Assignment
Masking: Double
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 Suzanne Schuh, 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

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Suzanne Schuh, Staff Physician, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT00213226     History of Changes
Other Study ID Numbers: 0020010349
First Submitted: September 13, 2005
First Posted: September 21, 2005
Last Update Posted: May 13, 2014
Last Verified: May 2014

Keywords provided by Suzanne Schuh, 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
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action