Observational Study of Surgical Treatment of Necrotizing Enterocolotis

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.

Inclusion Criteria:

- Infants born 401-1,000 grams at birth enrolled in the NRN Generic Database

- Sage III NEC or isolated intestinal perforation

- Pediatric surgeon decision to perform surgery for suspected NEC or IP

Exclusion Criteria:

- Decision not to treat