Clinical Trial: Single Injection of Dexamethasone for Acute Bronchiolitis in Young Children

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Efficacy of Single Injection of Dexamethasone for Acute Bronchiolitis in Children Younger Than 2 Years Old: A Randomized, Double-Blind, Placebo Controlled Trial

Brief Summary: The purpose of this study was to determine whether a single intramuscular injection of dexamethasone decreased the duration of symptoms of acute bronchiolitis in young children.

Detailed Summary:

Acute bronchiolitis is an infection of the lower respiratory tract causing inflammation of the small airways, leading to bronchiolar obstruction. Corticosteroids are frequently prescribed as anti-inflammatory drugs. The usefulness of corticosteroids for this disease remains controversial, despite many randomized controlled trials (RCTs). Recently, a meta-analysis and systemic review showed significant improvement in clinical symptoms, length of hospital stay and duration of symptoms in children with this disease after treatment with various regimens of systemic corticosteroids.

Dexamethasone is a long acting corticosteroid with biologic half-life ranging from 36-72 hours. A single dose of dexamethasone has been the standard recommendation for the treatment of croup which has a similar pathophysiology without evidence of adverse effects. Furthermore, there is no previous report of this single dosage form of dexamethasone for the treatment of acute bronchiolitis in young children.


Sponsor: Khon Kaen University

Current Primary Outcome:

  • The time from study entry to respiratory distress resolved, which was defined as the following: respiratory rate score of 0 or 1
  • wheezing score of 0 or 1
  • retraction muscle score of 0 or 1
  • and oxygen saturation greater than or equal to 95% without oxygen


Original Primary Outcome: The time from study entry to respiratory distress resolved, which was defined as the followings: respiratory rate score of 0 or 1, wheezing score of 0 or 1, retraction muscle score of 0 or 1, and oxygen saturation more than or equal 95% without oxygen.

Current Secondary Outcome:

  • The duration of oxygen therapy
  • The length of hospital stay
  • Additional drugs used
  • Emergency visit and hospital readmission within one month after discharge
  • Adverse drug events


Original Secondary Outcome: The duration of oxygen therapy, the length of hospital stay, additional drugs used, emergency visit and hospital readmission within one month after discharge, and adverse drug events.

Information By: Khon Kaen University

Dates:
Date Received: July 18, 2005
Date Started: April 2002
Date Completion: September 2004
Last Updated: July 28, 2005
Last Verified: February 2005