Project Goal

To compare the efficacy of laparotomy and peritoneal drainage as primary therapy for neonates diagnosed with perforated Necrotizing Enterocolitis (NEC).

Study Design

NECSteps is a multi-center randomized clinical trial to determine the optimal surgical management for neonates diagnosed with perforated NEC. Study outcomes determined from mortality, length of hospital stay and clinical outcomes data.

Study Sites

15 medical centers throughout North America:

• Baylor College of Medicine, Texas Children's Hospital
• Columbia University, Children's Hospital of NY
• George Washington University, Children's National Medical Center
• Medical College of Wisconsin, Children's Hospital of Wisconsin
• Ohio State University, Columbus Children’s Hospital
• Stanford University, Packard Children's Hospital
• University of Alabama Birmingham Children's Hospital
• University of California San Francisco Moffitt Hospital, Department of Pediatrics
• University of Cincinnati Children's Hospital Medical Center
• University of Michigan, Mott Hospital
• University of Mississippi Medical Center, Division of Pediatric Surgery
• University of Pittsburgh, Children's Hospital of Pittsburgh
• University of Texas Health Sciences Center, Houston, Pediatric Surgery
• University of Toronto, Hospital for Sick Children
• Yale University School of Medicine, Yale New Haven Children's Hospital

Data Collection

Data Collection (PDF Files)

• Instructions for Data Collection
• Entrance Information/Follow-up Information
• Daily Information
• Late Events Information

• Manual of Operations for Pediatric Surgeons
• NECSteps Critical Pathway - PDF
• NECSteps Data Safety Monitoring Board

Data Management

Trial Db: Yale Center for Medical Informatics

Funding

NICHD (National Institute of Child Health and Human Development) RO1 #38462

Timeline

Status: Jan 2006

• Study closed to enrollment May 2005 with 117 infants enrolled
• Data analysis completed August 2005
• Manuscript submitted for publication Nov 2005