The Effectiveness of Oral Dexamethasone for Acute Bronchiolitis

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.

Conditions

• Bronchiolitis, Viral

Interventions

DRUG

dexamethasone

1mg/kg dexamethasone

DRUG

Placebo

1mg/kg placebo

Sponsors & Collaborators

• Children's Hospital of Philadelphia

  collaborator OTHER

• Children's Hospital of Michigan

  collaborator OTHER

• Children's Hospital Medical Center, Cincinnati

  collaborator OTHER

• Washington University School of Medicine

  collaborator OTHER

• Columbia University

  collaborator OTHER

• Children's National Research Institute

  collaborator OTHER

• Helen DeVos Children's Hospital

  collaborator OTHER

• Women & Children's Hospital of Buffalo

  collaborator OTHER

• University of Rochester

  collaborator OTHER

• NYU Langone Health

  collaborator OTHER

• Hurley Medical Center

  collaborator OTHER

• Boston Children's Hospital

  collaborator OTHER

• University of Maryland

  collaborator OTHER

• Johns Hopkins University

  collaborator OTHER

• Howard County General Hospital

  collaborator UNKNOWN

• University of California, Davis

  collaborator OTHER

• University of Utah

  lead OTHER

Principal Investigators

• Howard Corneli, MD · University of Utah

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

2 Months

Max Age

11 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2004-01-31

Primary Completion

2006-04-30

Completion

2006-04-30

Countries

• United States

Study Locations