The Effectiveness of Oral Dexamethasone for Acute Bronchiolitis
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||The Effectiveness of Oral Dexamethasone for Acute Bronchiolitis: A Multicenter Randomized Controlled Trial|
- Hospital admission after 4 hours of ED observation [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
- Severity of disease measured by respiratory (RDAI) scores, vital signs, and oximetry. [ Time Frame: 4 hours ] [ Designated as safety issue: Yes ]
- Duration of hospitalization (if admitted) measured at 7-to-10 day followup. [ Time Frame: 7-10 days ] [ Designated as safety issue: Yes ]
- Safety, toleration, and parental satisfaction measured at 7-to-10 day followup. [ Time Frame: 7-10 days ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2004|
|Study Completion Date:||April 2006|
|Primary Completion Date:||April 2006 (Final data collection date for primary outcome measure)|
Active Comparator: Dexamethasone
1mg of Dexamethasone/kg
Placebo Comparator: Placebo
Bronchiolitis is the most common lower respiratory infection in infants, and the respiratory condition leading to the most hospital admissions in young children. It is also probably the most common serious illness of childhood lacking evidence-based treatment. Evidence both for and against the effectiveness of corticosteroids such as dexamethasone has been published. Editorials, expert reviews, and a recent report from the Agency for Healthcare Research and Quality recommend a study such as this one.
Patients will be drawn from the emergency departments at participating medical centers in the Pediatric Emergency Care Applied Research Network, created by the Emergency Medical Services for Children program and the Maternal and Child Health Bureau of the Health Resources and Services Administration to study health problems of high acuity and high incidence in children.
Comparisons: The primary outcome (hospital admission after 4 hours of ED observation) and secondary outcomes will be compared between treatment and placebo groups.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00119002
|United States, Utah|
|Primary Children's Medical Center|
|Salt Lake City, Utah, United States, 84158-0249|
|Principal Investigator:||Howard Corneli, MD||University of Utah|