Single Injection of Dexamethasone for Acute Bronchiolitis in Young Children
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|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|
- 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
- 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
|Study Start Date:||April 2002|
|Estimated Study Completion Date:||September 2004|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00122785
|Srinagarind Hospital, Khon Kaen University and Khon Kaen Hospital, Ministry of Public Health|
|Khon Kaen, Thailand, 40002|
|Principal Investigator:||Jamaree Teeratakulpisarn, M.D.||Faculty of Medicine, Khon Kaen University, Thailand|