Published online March 20, 2006
PEDIATRICS Vol. 117 No. 4 April 2006, pp. e680-e687 (doi:10.1542/10.1542/peds.2005-1273)

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Laparotomy Versus Peritoneal Drainage for Necrotizing Enterocolitis or Isolated Intestinal Perforation in Extremely Low Birth Weight Infants: Outcomes Through 18 Months Adjusted Age

Martin L. Blakely, MD^a, Jon E. Tyson, MD, MPH^b, Kevin P. Lally, MD^a, Scott McDonald, BS^c, Barbara J. Stoll, MD^d, David K. Stevenson, MD^e, W. Kenneth Poole, PhD^f, Alan H. Jobe, MD^g, Linda L. Wright, MD^h, Rosemary D. Higgins, MDⁱ for the NICHD Neonatal Research Network

^a Section of Pediatric Surgery, University of Tennessee Health Science Center, Memphis, Tennessee
^b Department of Neonatology, University of Texas Health Science Center, Houston, Texas
^c RTI International, Research Triangle Park, North Carolina
^d Department of Neonatology, Emory University, Atlanta, Georgia
^e Department of Neonatology, Stanford University School of Medicine, Palo Alto, CA
^f Department of Neonatology, Research Triangle Institute, Research Triangle Park, North Carolina
^g Department of Pediatrics, University of Cincinnati, Cincinnati, Ohio
^h Department of Neonatology, National Institute of Child Health and Human Development, Center for Research for Mothers and Children, Bethesda, MD
ⁱ Department of Neonatology, National Institute of Child Health and Human Development, Center for Development Biology and Perinatal Medicine, Bethesda, MD

OBJECTIVE. Extremely low birth weight (ELBW; 1000 g) infants with necrotizing enterocolitis (NEC) or isolated intestinal perforation (IP) are treated surgically with either initial laparotomy or peritoneal drain placement. The only published data comparing these therapies are from small, retrospective, single-center studies that do not address outcomes beyond nursery discharge. The objective of this study was to conduct a prospective, multicenter, observational study to (1) develop a hypothesis about the relative effect of these 2 therapies on risk-adjusted outcomes through 18 to 22 months in ELBW infants and (2) to obtain data that would be useful in designing and conducting a successful trial of this hypothesis.

METHODS. A prospective, cohort study was conducted at 16 clinical centers within the National Institute of Child Health and Human Development Neonatal Research Network. To assist in risk adjustment, the attending pediatric surgeon recorded the preoperative diagnosis and intraoperative diagnosis and identified infants who were considered to be too ill for laparotomy. Predefined measures of short- and longer-term outcome included (1) either predischarge death or prolonged parenteral nutrition (>85 days) after enrollment and (2) either death or neurodevelopmental impairment on a standardized examination at 18 to 22 months' adjusted age.

RESULTS. Severe NEC or IP occurred in 156 (5.2%) of 2987 ELBW infants; 80 were treated with initial drainage, and 76 were treated with initial laparotomy. By 18 to 22 months, 78 (50%) had died; 112 (72%) had died or were shown to be impaired. Outcome was worse in the subgroup with NEC. Laparotomy was never performed in 76% (28 of 36) of drain-treated survivors.

CONCLUSIONS. Drainage was commonly used, and outcome was poor. Our findings, particularly the risk-adjusted odds ratio favoring laparotomy for death or impairment, indicate the need for a large, multicenter clinical trial to assess the effect of the initial surgical therapy on outcome at 18 months.

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Key Words: necrotizing enterocolitis • neonatal surgery • neurodevelopmental outcomes

Abbreviations: NEC—necrotizing enterocolitis • ELBW—extremely low birth weight • NICHD—National Institute of Child Health and Human Development • NDI—neurodevelopmental impairment • IP—intestinal perforation • PN—parenteral nutrition • CP—cerebral palsy • HFOV—high-frequency oscillator ventilation • PIP—peak inspiratory pressure • OR—odds ratio • CI—confidence interval

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Accepted Sep 19, 2005.

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