Overview

The Effectiveness of Oral Dexamethasone for Acute Bronchiolitis

Status:
Completed
Trial end date:
2006-04-01
Target enrollment:
Participant gender:
Summary
This study will compare a single dose of oral dexamethasone to placebo in a multicenter, randomized, double blind trial of infants aged 2 to 12 months with first-time bronchiolitis (defined as wheezing within 7 days of onset). This is given as additional therapy beyond any other routine therapy used at that center. No current standard therapy is withheld, and no additional tests or other treatments are part of the study.The primary hypothesis is that dexamethasone will be more effective than placebo in preventing hospital admission. The secondary hypotheses are that dexamethasone will decrease respiratory scores and possibly the duration of the disease when compared to placebo, and that dexamethasone will be as safe and as well tolerated as placebo.
Phase:
Phase 4
Details
Lead Sponsor:
University of Utah
Collaborators:
Boston Children's Hospital
Boston Children’s Hospital
Children's Hospital Medical Center, Cincinnati
Children's Hospital of Michigan
Children's Hospital of Philadelphia
Children's National Research Institute
Children's Research Institute
Columbia University
Helen DeVos Children's Hospital
Howard County General Hospital
Hurley Medical Center
Johns Hopkins University
New York University School of Medicine
NYU Langone Health
University of California, Davis
University of Maryland
University of Maryland, College Park
University of Rochester
Washington University School of Medicine
Women & Children's Hospital of Buffalo
Treatments:
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate