The Effectiveness of Oral Dexamethasone for Acute Bronchiolitis

This study has been completed.
Sponsor:
Collaborators:
Children's Hospital of Philadelphia
Children's Hospital of Michigan
Children's Hospital Medical Center, Cincinnati
Washington University School of Medicine
Columbia University
Childrens Research Institute
Helen DeVos Children's Hospital
Women & Children's Hospital of Buffalo
University of Rochester
New York University School of Medicine
Hurley Medical Center
Children's Hospital Boston
University of Maryland
Johns Hopkins University
Howard County General Hospital
University of California, Davis
Information provided by:
University of Utah
ClinicalTrials.gov Identifier:
NCT00119002
First received: July 1, 2005
Last updated: March 13, 2008
Last verified: January 2008
  Purpose

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.


Condition Intervention Phase
Bronchiolitis, Viral
Drug: dexamethasone
Drug: Placebo
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Hospital admission after 4 hours of ED observation [ Time Frame: 4 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 598
Study Start Date: January 2004
Study Completion Date: April 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Dexamethasone
1mg of Dexamethasone/kg
Drug: dexamethasone
1mg/kg dexamethasone
Placebo Comparator: Placebo
1mg/kg placebo
Drug: Placebo
1mg/kg 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.

  Eligibility

Ages Eligible for Study:   2 Months to 11 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00119002

Locations
United States, Utah
Primary Children's Medical Center
Salt Lake City, Utah, United States, 84158-0249
Sponsors and Collaborators
University of Utah
Children's Hospital of Philadelphia
Children's Hospital of Michigan
Children's Hospital Medical Center, Cincinnati
Washington University School of Medicine
Columbia University
Childrens Research Institute
Helen DeVos Children's Hospital
Women & Children's Hospital of Buffalo
University of Rochester
New York University School of Medicine
Hurley Medical Center
Children's Hospital Boston
University of Maryland
Johns Hopkins University
Howard County General Hospital
University of California, Davis
Investigators
Principal Investigator: Howard Corneli, MD University of Utah
  More Information

Additional Information:
Publications:
Responsible Party: Howard Corneli, MD Principal Investigator, University of Utah
ClinicalTrials.gov Identifier: NCT00119002     History of Changes
Other Study ID Numbers: R40MC04298-01-00
Study First Received: July 1, 2005
Last Updated: March 13, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Utah:
randomized clinical trial
placebo-controlled
double-blind
double-masked
infant
dexamethasone
wheezing

Additional relevant MeSH terms:
Bronchiolitis
Bronchiolitis, Viral
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Virus Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 28, 2014