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A correction has been published: N Engl J Med 2006;355(8):856.
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Background Perforated necrotizing enterocolitis is a major cause of morbidity and mortality in premature infants, and the optimal treatment is uncertain. We designed this multicenter randomized trial to compare outcomes of primary peritoneal drainage with laparotomy and bowel resection in preterm infants with perforated necrotizing enterocolitis.
Methods We randomly assigned 117 preterm infants (delivered before 34 weeks of gestation) with birth weights less than 1500 g and perforated necrotizing enterocolitis at 15 pediatric centers to undergo primary peritoneal drainage or laparotomy with bowel resection. Postoperative care was standardized. The primary outcome was survival at 90 days postoperatively. Secondary outcomes included dependence on parenteral nutrition 90 days postoperatively and length of hospital stay.
Results At 90 days postoperatively, 19 of 55 infants assigned to primary peritoneal drainage had died (34.5 percent), as compared with 22 of 62 infants assigned to laparotomy (35.5 percent, P=0.92). The percentages of infants who depended on total parenteral nutrition were 17 of 36 (47.2 percent) in the peritoneal-drainage group and 16 of 40 (40.0 percent) in the laparotomy group (P=0.53). The mean (±SD) length of hospitalization for the 76 infants who were alive 90 days after operation was similar in the primary peritoneal-drainage and laparotomy groups (126±58 days and 116±56 days, respectively; P=0.43). Subgroup analyses stratified according to the presence or absence of radiographic evidence of extensive necrotizing enterocolitis (pneumatosis intestinalis), gestational age of less than 25 weeks, and serum pH less than 7.30 at presentation showed no significant advantage of either treatment in any group.
Conclusions The type of operation performed for perforated necrotizing enterocolitis does not influence survival or other clinically important early outcomes in preterm infants. (ClinicalTrials.gov number, NCT00252681
[ClinicalTrials.gov]
.)
Source Information
From the Section of Pediatric Surgery, Yale University School of Medicine, New Haven, Conn. (R.L.M., B.L.S.); the Divisions of Neonatology (R.A.D.) and Pediatric Surgery (D.C.B.), University of Alabama, Birmingham; and the Division of Pediatric Surgery at each of the following institutions: Stanford University School of Medicine, Stanford, Calif. (K.G.S.); Cincinnati Children's Hospital and Medical Center, Cincinnati (R.L.B.); Children's National Medical Center, Washington, D.C. (D.M.P.); University of Mississippi School of Medicine, Jackson (S.I.); University of Toronto Faculty of Medicine, Toronto (J.C.L.); Children's Hospital of Wisconsin, Milwaukee (T.T.S.); Texas Children's Hospital, Houston (M.L. Brandt); University of California, San Francisco, School of Medicine, San Francisco (H.L.); University of Tennessee Health Science Center, Memphis (M.L. Blakely); Morristown Memorial Hospital, Morristown, N.J. (E.L.L.); University of Michigan Medical School, Ann Arbor (R.B.H.); Columbus Children's Hospital, Columbus, Ohio (B.D.K.); University of Pittsburgh School of Medicine, Pittsburgh (D.J.H.); and Yale School of Epidemiology and Public Health, New Haven, Conn. (D.Z.).
Address reprint requests to Dr. Moss at Yale University School of Medicine, Section of Pediatric Surgery, 333 Cedar St., FMB 132, P.O. Box 208062, New Haven, CT 06520-8062, or at larry.moss{at}yale.edu.
Related Letters:
Treatment of Necrotizing Enterocolitis
Gordon P. V., Rees C. M., Eaton S., Pierro A., Moss R. L., Brandt C.
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N Engl J Med 2006;
355:846-847, Aug 24, 2006.
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