Dexamethasone for Bronchiolitis RCT: A PECARN Project
Grantee: University of Utah
Principal Investigator: Howard Corneli
Project Number: R40MC04298
Project Date: 01/02/2005
Final Report
Dexamethasone for Bronchiolitis RCT: A PECARN Project Final Report (PDF)
Age group(s)
- Perinatal/Infancy (0-12 months)
Abstract
Bronchiolitis is the most common lower respiratory infection of infants. It is associated with rapidly increasing hospital admission rates. Bronchiolitis is also one of the most common serious illnesses of childhood lacking evidence-based treatment. Despite previous negative trials, a recent small study suggested that oral dexamethasone in a single dose of 1 mg/kg may markedly decrease the need for hospital admission, and experts have urged a large, randomized, placebo controlled, double blind, multi-center trial of this medication. This project aims to continue such a trial, which has enrolled 200 infants thus far but requires 600 more to provide a definitive answer to this question. This project is especially relevant to MCHB Strategic Research Issues III and IV. This study will assess the effectiveness of oral dexamethasone for acute moderate-to-severe outpatient infant bronchiolitis in a multi-center randomized controlled trial, taking as outcomes: (1) The need for hospital admission (primary outcome); (2) Clinical severity, measured by respiratory scores; (3) Duration of hospitalization (if admitted); (4) The safety of this treatment. This project will continue a trial begun using existing resources at 16 medical centers in the EMSC/MCHB Pediatric Emergency Care Applied Research Network (PECARN). Results of the first year's efforts show impressive parent acceptance of the study, nearly flawless randomization and blinding, complete and valid data collection, excellent follow-up rates, and apparent safety thus far. Study participation requires four hours of observation in the Emergency Department and a single, follow-up telephone call after 7 to 10 days. The PECARN network and this trial have a tested and efficient administrative, data management, and study coordination system already in place. The study is designed to achieve 90% power to detect an effect size less than half that seen in the previously mentioned study, and will seek to enroll approximately 400 patients in each group. The study is powered to provide definitive answers to the questions posed.Publications
Listed is descending order by year published.
Corneli HM, Zorc JJ, Holubkov R, et al. Bronchiolitis: presenting characteristics associated with hospitalization and length of stay. Pediatric Emergency Care. 2012:28(2);99-103.
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