The Effectiveness of Oral Dexamethasone for Acute Bronchiolitis

• Status: Completed
• Trial end date: 2006-04-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

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

Criteria

Inclusion Criteria:

• First attack of wheezing within 7 days of onset

• Age 2 months through 11 months (less than 12 months)

• Disease of at least moderate severity (RDAI score greater than or equal to 6)

Exclusion Criteria:

• Prior adverse reaction to dexamethasone

• Known heart or lung disease

• Premature birth prior to 36 weeks' gestation

• History of prior asthma or bronchodilator use

• Immune suppression or deficiency

• Trisomy 21

• Critical or life-threatening complications of bronchiolitis

• Treatment with corticosteroids within 14 days

• Known active chickenpox

• Exposure to chickenpox within 21 days

• Child sent to ED for automatic admission