Clinical Trial: Observational Study of Surgical Treatment of Necrotizing Enterocolotis

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Observational Study of Surgical Treatment of Necrotizing Enterocolotis or Isolated Intestinal Perforation

Brief Summary: The purposes of this study were: 1) to compare mortality and postoperative morbidities in extremely low birth weight (ELBW) infants who underwent initial laparotomy or drainage for necrotizing enterocolitis (NEC) or isolated intestinal perforation (IP); 2) to determine the ability to distinguish NEC from IP preoperatively and the importance of this distinction on outcome measures; and 3) to evaluate the association between extent of intestinal disease determined at operation and outcome measures. All ELBW infants born at participating NRN centers were screened for the presence of NEC or IP that was thought by the pediatric surgeon and neonatologist to require surgical intervention. Data were collected enrolled infants, including: intraoperative findings recorded by the surgeon and specific post-operative complications. Neurodevelopmental examinations were conducted on surviving infants at 18-22 months corrected age.

Detailed Summary:

Necrotizing enterocolitis (NEC) is a condition, generally affecting premature infants, in which the intestines become ischemic (lack oxygen and/or blood flow). NEC occurs in up to 5-15% of extremely low birth weight (ELBW) infants. Isolated or focal intestinal perforation (IP) is a less common condition, affecting an estimated 4% of ELBWs, in which a hole develops in the intestines leaking fluid into the abdomin. The outcomes for infants with NEC or IP are poor: 49% die and half of the surviving infants are neurodevelopmentally impaired.

Surgical options for NEC and IP include two possible procedures: peritoneal drainage, in which a tube is placed in the abdominal cavity through a small incision for fluid to drain out; or laparotomy, in which an incision is made in the abdomen and diseased intestine is removed. Infants treated with an initial drainage sometimes go on to need a laparotomy. Most surgeons now believe that a diagnosis of the intestinal perforation (IP) may actually be either true NEC or a different and distinct pathology, termed isolated intestinal perforation. The ability to distinguish these 2 conditions preoperatively, based on perinatal characteristics, physical examination findings, and findings on abdominal plain film imaging, remains unknown. If these 2 entities can be distinguished preoperatively, the intervention chosen and outcomes may be different. From the two available surgical options, tt is not known whether initial laparotomy or peritoneal drain placement is more effective for either NEC or IP.

This study was a prospective, multicenter observational study to describe the surgical outcomes (mortality, post-operative intestinal stricture, intra-abdominal abscess formation, etc.) in ELBW infants with either NEC or IP who underwent initial laparotomy or peritoneal drainage. We also evaluated the ab
Sponsor: NICHD Neonatal Research Network

Current Primary Outcome: Feasibility of conducting a randomized trial [ Time Frame: 1 year ]

Ability to enroll infants in a 1-year period


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Document variation in current surgical practices [ Time Frame: Until hospital discharge or 120 days of life ]
  • Prevalence of infants who would qualify for the study [ Time Frame: Until hospital discharge or 120 days of life ]
  • Frequency of postoperative complications [ Time Frame: Until hospital discharge or 120 days of life ]
  • Neurodevelopmental impairment [ Time Frame: 18-22 months corrected age ]


Original Secondary Outcome: Same as current

Information By: NICHD Neonatal Research Network

Dates:
Date Received: October 14, 2010
Date Started: March 2001
Date Completion:
Last Updated: June 3, 2015
Last Verified: June 2015