MARC-30: Prospective Multicenter Study of Bronchiolitis Admissions

Investigators:
Carlos A. Camargo, MD, DrPH, Massachusetts General Hospital, Boston, MA
Jonathan Mansbach, MD, Children’s Hospital, Boston, MA
Pedro A. Piedra, MD, Baylor College of Medicine, Houston, TX
Monica Kleinman, MD, Children’s Hospital, Boston, MA
Ashley F. Sullivan, MS, MPH, Massachusetts General Hospital, Boston, MA

Funding Source: National Institutes of Health (U01 AI67693)

Purpose: (1) To elucidate the role of multiple pathogen infections and to determine the utility of PCR-testing for an infectious etiology; (2) To create high-risk and low-risk clinical rules to predict reliably those children with bronchiolitis who would require continuous positive airway pressure or intubation and those who would not require intensive care; and (3) To develop hospital discharge guidelines that encourage earlier, but safe discharges and foster family-centered care.

Rationale: Bronchiolitis is the leading cause of hospitalization for infants and the associated hospitalization costs are > $500 million per year. However, there is a lack of consensus about the optimal management for children with this common disease. To our knowledge, no prospective, multicenter study in the US has systematically used PCR testing to detect over several years known and recently emerging infectious agents in children diagnosed with bronchiolitis, the correlating clinical characteristics, and short term outcomes. Therefore, these data will advance the creation of an evidenced-based guideline for testing children with bronchiolitis and help determine the clinical significance of particular infections. The study will also help clinicians make evidence-based decisions regarding the level of monitoring required and help prioritize the transfer of sick children to facilities with a pediatric intensive care unit. Finally, the study will provide data that would encourage clinicians to use their clinical judgment and to involve families in the care process.

Procedure: This study will include children age < 2 years hospitalized with a primary diagnosis of bronchiolitis at 15 different EMNet hospitals. The study will be coordinated by the EMNet Coordinating Center (Boston, MA). PCR testing will be performed at Baylor College of Medicine (Houston, TX). In brief, we will collect data for 3 consecutive years from November until April, beginning in 2007. We will enroll and have 1-week post discharge telephone follow-up for a total 2,250 patients. Each of the 15 sites will be asked to enroll patients consecutively until reaching the monthly quota. The required sample size per bronchiolitis season (November to March) is 50 patients per site, with at least 10 patients being enrolled from the ICU. There will be time for catch-up to ensure we attain the target sample size, while still enrolling patients during each month of the bronchiolitis season.

Site and patient Data will come from seven sources: site PI questionnaire (Site Form), hospital interview and chart review (Visit Form), Hospital Provider (HP Form), daily chart review (Daily Inpatient Form), telephone interview one week after discharge (Follow-Up Form), chart review of the missed patients (Missed Case Form), and the Bronchiolitis Registry (including Registry Form). Nasopharyngeal aspirate specimens also will be collected.