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
|Condition or disease||Intervention/treatment||Phase|
|Bronchiolitis, Viral||Drug: dexamethasone Drug: Placebo||Phase 4|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||598 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||The Effectiveness of Oral Dexamethasone for Acute Bronchiolitis: A Multicenter Randomized Controlled Trial|
|Study Start Date :||January 2004|
|Primary Completion Date :||April 2006|
|Study Completion Date :||April 2006|
Active Comparator: Dexamethasone
1mg of Dexamethasone/kg
Placebo Comparator: Placebo
- Hospital admission after 4 hours of ED observation [ Time Frame: 4 hours ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00119002
|United States, Utah|
|Primary Children's Medical Center|
|Salt Lake City, Utah, United States, 84158-0249|
|Principal Investigator:||Howard Corneli, MD||University of Utah|