Observational Study of Surgical Treatment of Necrotizing Enterocolotis (NEC Surgery)

• Feasibility of conducting a randomized trial [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  Ability to enroll infants in a 1-year period
  
  

• Document variation in current surgical practices [ Time Frame: Until hospital discharge or 120 days of life ] [ Designated as safety issue: No ]
  
• Prevalence of infants who would qualify for the study [ Time Frame: Until hospital discharge or 120 days of life ] [ Designated as safety issue: No ]
  
• Frequency of postoperative complications [ Time Frame: Until hospital discharge or 120 days of life ] [ Designated as safety issue: Yes ]
  
• Neurodevelopmental impairment [ Time Frame: 18-22 months corrected age ] [ Designated as safety issue: Yes ]
  

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 ability of surgeons to distinguish NEC and IP pre-operatively and the relevance of this distinction on outcome. Finally, an analysis of the impact of extent of intestinal involvement with NEC on outcome measures is reported.

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.