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Sponsors and Collaborators: |
Yale University Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) National Center for Research Resources (NCRR) |
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Information provided by: | Yale University |
ClinicalTrials.gov Identifier: | NCT00252681 |
The primary purpose of this study is to compare two surgical treatments for perforated necrotizing enterocolitis in very low birth weight babies.
Condition | Intervention |
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Necrotizing Enterocolitis |
Procedure: laparotomy Procedure: primary peritoneal drainage |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Surgery for Necrotizing Enterocolitis in Human Infants: A Randomized Trial |
Estimated Enrollment: | 130 |
Study Start Date: | July 1999 |
Estimated Study Completion Date: | June 2005 |
This is a multi-center randomized clinical trial comparing laparotomy vs peritoneal drainage for perforated Necrotizing Enterocolitis. The current literature does not allow an objective comparison between these two methods. A recent comprehensive meta-analysis of all published and much unpublished data regarding the use of these procedures in the treatment of perforated NEC revealed that the degree of bias in assignment to treatment precluded an adequate determination as to the best treatment. The conclusion that only a randomized clinical trial would answer this question has led to this multi-center effort. The relative infrequency of the disease at any one neonatal center has necessitated enrollment of patients at many centers.
Comparison: Premature neonates weighing less than 1500 grams at birth who develop perforated necrotizing enterocolitis are randomized within two birth weight blocks (<1000 gms and 1000 - 1499 gms) for treatment with either laparotomy or primary peritoneal drainage. Daily postoperative clinical care is kept uniform between the two groups by means of a critical care pathway. The primary outcome variable is mortality, i.e. death within 90 days of intervention. The main secondary outcome is short bowel syndrome - defined as the need for chronic parenteral nutrition greater than 3 months following operation.
Ages Eligible for Study: | up to 3 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Connecticut | |
Yale University School of Medicine Section of Pediatric Surgery | |
New Haven, Connecticut, United States, 06520 |
Principal Investigator: | R. Lawrence Moss, MD | Yale University |
Study ID Numbers: | RO1 HD38462, Gen Clin Res Ctr #M01-RR00125 |
Study First Received: | November 9, 2005 |
Last Updated: | July 20, 2006 |
ClinicalTrials.gov Identifier: | NCT00252681 |
Health Authority: | United States: Institutional Review Board |
randomized controlled trial necrotizing enterocolitis |
premature infants laparotomy peritoneal drainage |
Digestive System Diseases Gastrointestinal Diseases Necrotizing enterocolitis Intestinal Diseases |
Gastroenteritis Enterocolitis, Necrotizing Enterocolitis |