This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The best treatment for premature infants with perforated bowel due to necrotizing enterocolitis (NEC) is unknown. The traditional therapy includes emergency laparotomy and bowel resection. A widely practiced minimally invasive alternative is bedside drainage of the peritoneal cavity, without bowel resection. Primary peritoneal drainage (PPD) was originally developed for moribund infant, but has evolved into a promising novel strategy for all patients with perforated NEC. However, experience at a given institution is too small to be considered anything but anecdotal, and the published reports are uncontrolled and retrospective. 'Colloquial' beliefs about which method is superior are so strong that a randomized trial has never even been proposed. We intend to use the resources at Lucile Packard Children's Hospital to perform a prospective randomized trial with the following specific aims: 1. We will determine whether PPD improves survival over conventional operative management for low birth weight (less than 1500 grams) premature infants with perforated NEC. Conventional operative management includes laparotomy (LAP), with bowel resection and creation of intestinal stomas (LAP). We will attempt to enroll all patients meeting the above criteria and randomize them to PPD or LAP. We will directly compare early and late mortality between the two groups. 2. We will determine whether PPD decreases morbidity of perforated NEC in low birth weight infants. Survivors of NEC are at risk for short bowel syndrome and parenteral nutrition induced liver failure. We will directly compare the incidence of short bowel syndrome and the need for parenteral nutrition between the two groups. 3. We will determine whether PPD decreases the length of hospital stay or the cost of medical care in low birth weight babies with NEC. We will compare length of hospital stay, length of intensive care stay, and hospital cost between the two groups.

National Institute of Health (NIH)
National Center for Research Resources (NCRR)
General Clinical Research Centers Program (M01)
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Stanford University
Internal Medicine/Medicine
Schools of Medicine
United States
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