Viewing Study NCT00122785



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Study NCT ID: NCT00122785
Status: COMPLETED
Last Update Posted: 2005-07-29
First Post: 2005-07-18

Brief Title: Single Injection of Dexamethasone for Acute Bronchiolitis in Young Children
Sponsor: Khon Kaen University
Organization: Khon Kaen University

Study Overview

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
Status: COMPLETED
Status Verified Date: 2005-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 Description: 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None