The Effectiveness of Oral Dexamethasone for Acute Bronchiolitis

Bronchiolitis, Viral Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00119002
• Other study ID #: R40MC04298-01-00
• Status: Completed
• Phase: Phase 4
• First received: July 1, 2005
• Last updated: March 13, 2008
• Start date: January 2004
• Est. completion date: April 2006

Study information

• Verified date: January 2008
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 598
• Est. completion date: April 2006
• Est. primary completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Months to 11 Months

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bronchiolitis
• Bronchiolitis, Viral

Intervention

Drug:
• dexamethasone
1mg/kg dexamethasone
• Placebo
1mg/kg placebo

Locations

Country	Name	City	State
United States	Primary Children's Medical Center	Salt Lake City	Utah

Sponsors (17)

Lead Sponsor

Collaborator

University of Utah

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

Country where clinical trial is conducted

United States, 

References & Publications (1)

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; Bronch — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital admission after 4 hours of ED observation		4 hours	No
Secondary	Severity of disease measured by respiratory (RDAI) scores, vital signs, and oximetry.		4 hours	Yes
Secondary	Duration of hospitalization (if admitted) measured at 7-to-10 day followup.		7-10 days	Yes
Secondary	Safety, toleration, and parental satisfaction measured at 7-to-10 day followup.		7-10 days	Yes

External Links

•   Pediatric Emergency Care Applied Research Network (PECARN)