A Multi-center Randomized Trial of Laparotomy vs. Drainage as the Initial Surgical Therapy for ELBW Infants with Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP): Outcomes at 18-22 months Adjusted Age

This was a multicenter, randomized clinical trial to determine which initial surgical treatment resulted in the lowest rate of death or neurodevelopmental impairment (NDI) in premature infants with necrotizing enterocolitis (NEC) or isolated intestinal perforation (IP). The randomized cohort included 308 infants aged ? 8 0/7 weeks of age and ? 1,000 g birthweight that were born at centers with the ability to perform both laparotomy and drainage for which a decision was made by the attending pediatric surgeon to perform surgery for suspected NEC or IP. Death or NDI occurred in 69% of infants in the laparotomy group versus 70% with drainage. There was no overall difference in death or NDI rates at 18 to 22 months corrected age between initial laparotomy versus drainage. However, the preoperative diagnosis of NEC or IP modified the impact of initial treatment.