Study Type: Interventional
Study Period: April 2007- November 2009
Despite use of CDC recommended preventive strategies, nosocomial infection / sepsis occurs in up to 40% of children requiring long stay intensive care. Since lymphopenia and protein malnutrition are known risk factors, we evaluated whether directed nutriceutical supplements would reduce nosocomial infection / sepsis. A multicenter randomized double-blinded comparative trial was conducted to determine if enteral zinc, selenium, glutamine and IV metoclopramide (ZSGM) would reduce nosocomial infection / sepsis compared with enteral whey protein (WHEY) and IV placebo, when administered for up to 28 days of Pediatric Intensive Care Unit (PICU) stay.
- CRISIS Annotated PUD eCRF (PDF)
- CRISIS Protocol (PDF)
- Overview (PDF)
- CRISIS Endpoint Adjudication (PDF)
- CDC Definitions of Nosocomial Infections (PDF)
- To obtain the Public Release Research Dataset follow the procedures outlined on the NICHD Data and Specimen Hub (DASH) website.