Abstract | 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: 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.).
|
Authors | R Lawrence Moss, Reed A Dimmitt, Douglas C Barnhart, Karl G Sylvester, Rebeccah L Brown, David M Powell, Saleem Islam, Jacob C Langer, Thomas T Sato, Mary L Brandt, Hanmin Lee, Martin L Blakely, Eric L Lazar, Ronald B Hirschl, Brian D Kenney, David J Hackam, Daniel Zelterman, Bonnie L Silverman |
Journal | The New England journal of medicine
(N Engl J Med)
Vol. 354
Issue 21
Pg. 2225-34
(May 25 2006)
ISSN: 1533-4406 [Electronic] United States |
PMID | 16723614
(Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, N.I.H., Extramural)
|
Copyright | Copyright 2006 Massachusetts Medical Society. |
Topics |
- Birth Weight
- Drainage
- Enterocolitis, Necrotizing
(complications, mortality, surgery, therapy)
- Female
- Humans
- Infant, Newborn
- Infant, Premature
- Infant, Premature, Diseases
(mortality, surgery, therapy)
- Infant, Very Low Birth Weight
- Intestinal Perforation
(etiology, mortality, surgery, therapy)
- Laparotomy
- Male
- Parenteral Nutrition, Total
- Peritoneum
- Proportional Hazards Models
- Survival Analysis
- Treatment Outcome
|