NCT00119002

The Effectiveness of Oral Dexamethasone for Acute Bronchiolitis

The Effectiveness of Oral Dexamethasone for Acute Bronchiolitis: A Multicenter Randomized Controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 598 (actual)
• Sponsor: University of Utah · Academic / Other
• Sex: All
• Age: 2 Months – 11 Months
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Bronchiolitis, Viral

Interventions

Type	Name	Description
DRUG	dexamethasone	1mg/kg dexamethasone
DRUG	Placebo	1mg/kg placebo

Timeline

• Start date: 2004-01-01
• Primary completion: 2006-04-01
• Completion: 2006-04-01
• First posted: 2005-07-12
• Last updated: 2008-03-14

Locations

1 site across 1 country: United States