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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

July 1, 2005
March 13, 2008
January 2004
April 2006   (final data collection date for primary outcome measure)
Hospital admission after 4 hours of ED observation [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
Hospital admission after 4 hours of ED observation
Complete list of historical versions of study NCT00119002 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Severity of disease measured by respiratory (RDAI) scores, vital signs, and oximetry.
  • Duration of hospitalization (if admitted) measured at 7-to-10 day followup.
  • Safety, toleration, and parental satisfaction measured at 7-to-10 day followup.
Not Provided
Not Provided
 
The Effectiveness of Oral Dexamethasone for Acute Bronchiolitis
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Bronchiolitis, Viral
  • Drug: dexamethasone
    1mg/kg dexamethasone
  • Drug: Placebo
    1mg/kg placebo
  • Active Comparator: Dexamethasone
    1mg of Dexamethasone/kg
    Intervention: Drug: dexamethasone
  • Placebo Comparator: Placebo
    1mg/kg placebo
    Intervention: Drug: Placebo
Corneli HM, Zorc JJ, Majahan P, Shaw KN, Holubkov R, Reeves SD, Ruddy RM, Malik B, Nelson KA, Bregstein JS, Brown KM, Denenberg MN, Lillis KA, Cimpello LB, Tsung JW, Borgialli DA, Baskin MN, Teshome G, Goldstein MA, Monroe D, Dean JM, Kuppermann N; Bronchiolitis Study Group of the Pediatric Emergency Care Applied Research Network (PECARN). A multicenter, randomized, controlled trial of dexamethasone for bronchiolitis. N Engl J Med. 2007 Jul 26;357(4):331-9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
598
April 2006
April 2006   (final data collection date for primary outcome measure)

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
Both
2 Months to 11 Months
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00119002
R40MC04298-01-00
Yes
Howard Corneli, MD Principal Investigator, University of Utah
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
Principal Investigator: Howard Corneli, MD University of Utah
University of Utah
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP