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Completed

NCT Number: NCT00213226

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

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

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Key information

Conditions

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

Age range

2 month–24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone

Drug

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

  1. Respiratory Assessment Change Score (RACS) at 96 and 144 hours

  2. Proportion of infants with unscheduled medical visits for respiratory distress within the 6 day study period

  3. Proportion of infants with no signs of respiratory distress at 96 and 144 hours

  4. Proportion of infants who are symptomatic at 14 days

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Collaborators

  • The Physicians' Services Incorporated Foundation

Registry information

Official study title

Efficacy of Single Dose Versus Multiple Doses of Dexamethasone in Outpatients With Acute Bronchiolitis

Important dates

Study start
2001
Primary completion
2006
Study completion
2006
First posted
Sep 21, 2005
Registry last updated
May 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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