The Effectiveness of Oral Dexamethasone for Acute Bronchiolitis

• ClinicalTrials.gov Identifier: NCT00119002
• Recruitment Status: Completed
• First Posted: July 12, 2005
• Last Update Posted: March 14, 2008
• Sponsor: University of Utah
• 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

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Bronchiolitis, Viral	Drug: dexamethasone; Drug: Placebo	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 598 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: The Effectiveness of Oral Dexamethasone for Acute Bronchiolitis: A Multicenter Randomized Controlled Trial
• Study Start Date: January 2004
• Actual Primary Completion Date: April 2006
• Actual Study Completion Date: April 2006

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Hospital admission after 4 hours of ED observation [ Time Frame: 4 hours ]

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 2 Months to 11 Months (Child)
• Sexes Eligible for Study: All
• 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

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

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

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

More Information

Additional Information:

Pediatric Emergency Care Applied Research Network (PECARN) 

Publications of Results:

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].

• Responsible Party: Howard Corneli, MD Principal Investigator, University of Utah
• ClinicalTrials.gov Identifier: NCT00119002
• Other Study ID Numbers: R40MC04298-01-00
• First Posted: July 12, 2005
• Last Update Posted: March 14, 2008
• Last Verified: January 2008

Keywords provided by University of Utah:

randomized clinical trial; placebo-controlled; double-blind; double-masked; infant; dexamethasone; wheezing

Additional relevant MeSH terms:

Bronchiolitis, Viral; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Infections; Virus Diseases; Dexamethasone; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Antineoplastic Agents