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The Effectiveness of Oral Dexamethasone for Acute Bronchiolitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00119002
Recruitment Status : Completed
First Posted : July 12, 2005
Last Update Posted : March 14, 2008
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
Children's National Research Institute
Helen DeVos Children's Hospital
Women & Children's Hospital of Buffalo
University of Rochester
NYU Langone Health
Hurley Medical Center
Boston Children's Hospital
University of Maryland, College Park
Johns Hopkins University
Howard County General Hospital
University of California, Davis
Information provided by:
University of Utah

Tracking Information
First Submitted Date  ICMJE July 1, 2005
First Posted Date  ICMJE July 12, 2005
Last Update Posted Date March 14, 2008
Study Start Date  ICMJE January 2004
Actual Primary Completion Date April 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 24, 2008)
Hospital admission after 4 hours of ED observation [ Time Frame: 4 hours ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 1, 2005)
Hospital admission after 4 hours of ED observation
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 24, 2008)
  • Severity of disease measured by respiratory (RDAI) scores, vital signs, and oximetry. [ Time Frame: 4 hours ]
  • Duration of hospitalization (if admitted) measured at 7-to-10 day followup. [ Time Frame: 7-10 days ]
  • Safety, toleration, and parental satisfaction measured at 7-to-10 day followup. [ Time Frame: 7-10 days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 1, 2005)
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effectiveness of Oral Dexamethasone for Acute Bronchiolitis
Official Title  ICMJE The Effectiveness of Oral Dexamethasone for Acute Bronchiolitis: A Multicenter Randomized Controlled Trial
Brief 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Bronchiolitis, Viral
Intervention  ICMJE
  • Drug: dexamethasone
    1mg/kg dexamethasone
  • Drug: Placebo
    1mg/kg placebo
Study Arms  ICMJE
  • Active Comparator: Dexamethasone
    1mg of Dexamethasone/kg
    Intervention: Drug: dexamethasone
  • Placebo Comparator: Placebo
    1mg/kg placebo
    Intervention: Drug: Placebo
Publications * Corneli HM, Zorc JJ, Mahajan 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. Erratum in: N Engl J Med. 2008 Oct 30;359(18):1972.. Majahan, Prashant [corrected to Mahajan, Prashant].

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 24, 2008)
598
Original Enrollment  ICMJE
 (submitted: July 1, 2005)
600
Actual Study Completion Date  ICMJE April 2006
Actual Primary Completion Date April 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Months to 11 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00119002
Other Study ID Numbers  ICMJE R40MC04298-01-00
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Howard Corneli, MD Principal Investigator, University of Utah
Study Sponsor  ICMJE University of Utah
Collaborators  ICMJE
  • Children's Hospital of Philadelphia
  • Children's Hospital of Michigan
  • Children's Hospital Medical Center, Cincinnati
  • Washington University School of Medicine
  • Columbia University
  • Children's National Research Institute
  • Helen DeVos Children's Hospital
  • Women & Children's Hospital of Buffalo
  • University of Rochester
  • NYU Langone Health
  • Hurley Medical Center
  • Boston Children's Hospital
  • University of Maryland, College Park
  • Johns Hopkins University
  • Howard County General Hospital
  • University of California, Davis
Investigators  ICMJE
Principal Investigator: Howard Corneli, MD University of Utah
PRS Account University of Utah
Verification Date January 2008

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