Laparotomy vs. Drainage for Infants With Necrotizing Enterocolitis

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 abdominal cavity. Outcome for infants with NEC
and/or IP is 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 necrotic intestine is
removed. Drainage may be followed by a laparotomy.

The Neonatal Research Network's observational study of 156 ELBW infants with NEC or IP
(Pediatrics. 2006 Apr; 117(4): e680-7) showed comparable outcomes for the two procedures
before hospital discharge, but suggested an advantage of laparotomy over drainage at 18-22
months corrected age with lower rates of death or neurodevelopmental impairment. However, the
infants that underwent laparotomy were more mature; infants with drains were smaller and more
premature. We hypothesize that initial laparotomy may improve an infant's long-term
neurodevelopmental outcome, potentially by reducing the maximum severity or duration of
inflammation.

This study is a randomized controlled trial to compare the effectiveness of laparotomy versus
drainage for treating NEC or IP in extremely low birth weight infants. Target enrollment is
300 infants diagnosed with NEC or IP for randomization to receive initially either a
laparotomy or drainage. Subsequent laparotomies may be performed on infants in either group,
if their condition continues to deteriorate. Surviving infants will return for a follow-up
assessment at 18-22 months corrected age.

This trial uses a comprehensive cohort design that adds to the conventional randomized trial
design, as a secondary specific aim. In addition to collecting detailed information on the
randomized infants, we will also collect information on non-randomized infants with NEC/IP
who are officially enrolled into a preference cohort.

Inclusion Criteria:

- Infants born at ≤1,000 g birth weight

- Infant is ≤8 0/7 weeks of age at the time of eligibility assessment

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

- Subject is at a center able to perform both laparotomy and drainage

Exclusion Criteria:

- Major anomaly that influences likelihood of developing primary outcome or affects
surgical treatment considerations

- Congenital infection

- Prior laparotomy or peritoneal drain placement

- Prior NEC or IP

- Infant for whom full support is not being provided

- Follow-up unlikely