Status:
COMPLETED
The Effectiveness of Oral Dexamethasone for Acute Bronchiolitis
Lead Sponsor:
University of Utah
Collaborating Sponsors:
Children's Hospital of Philadelphia
Children's Hospital of Michigan
Conditions:
Bronchiolitis, Viral
Eligibility:
All Genders
2-11 years
Phase:
PHASE4
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 wheezin...
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 se...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2006
Estimated Enrollment :
598 Patients enrolled
Trial Details
Trial ID
NCT00119002
Start Date
January 1 2004
End Date
April 1 2006
Last Update
March 14 2008
Active Locations (1)
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1
Primary Children's Medical Center
Salt Lake City, Utah, United States, 84158-0249