The Effectiveness of Oral Dexamethasone for Acute Bronchiolitis

March 13, 2008 updated by: University of Utah

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

598

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84158-0249
        • Primary Children's Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 months to 11 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Dexamethasone
1mg of Dexamethasone/kg
Drug: dexamethasone
1mg/kg dexamethasone
Placebo Comparator: Placebo
1mg/kg placebo
Drug: Placebo
1mg/kg placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hospital admission after 4 hours of ED observation
Time Frame: 4 hours
4 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Severity of disease measured by respiratory (RDAI) scores, vital signs, and oximetry.
Time Frame: 4 hours
4 hours
Duration of hospitalization (if admitted) measured at 7-to-10 day followup.
Time Frame: 7-10 days
7-10 days
Safety, toleration, and parental satisfaction measured at 7-to-10 day followup.
Time Frame: 7-10 days
7-10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Collaborators

Johns Hopkins University
Children's Hospital of Philadelphia
Washington University School of Medicine
University of Maryland
Columbia University
NYU Langone Health
Boston Children's Hospital
University of California, Davis
Children's Hospital Medical Center, Cincinnati
University of Rochester
Children's National Research Institute
Children's Hospital of Michigan
Women & Children's Hospital of Buffalo
Hurley Medical Center
Helen DeVos Children's Hospital
Howard County General Hospital

Investigators

  • Principal Investigator: Howard Corneli, MD, University of Utah

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Primary Completion (Actual)

April 1, 2006

Study Completion (Actual)

April 1, 2006

Study Registration Dates

First Submitted

July 1, 2005

First Submitted That Met QC Criteria

July 1, 2005

First Posted (Estimate)

July 12, 2005

Study Record Updates

Last Update Posted (Estimate)

March 14, 2008

Last Update Submitted That Met QC Criteria

March 13, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R40MC04298-01-00

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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