Clinical Trial: Laparotomy vs. Drainage for Infants With Necrotizing Enterocolitis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Multi-center Randomized Trial of Laparotomy vs. Drainage as the Initial Surgical Therapy for ELBW Infants With Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforatio

Brief Summary: This trial will compare the effectiveness of two surgical procedures -laparotomy versus drainage - commonly used to treat necrotizing enterocolitis (NEC) or isolated intestinal perforations (IP) in extremely low birth weight infants (≤1,000 g). Infants diagnosed with NEC or IP requiring surgical intervention, will be recruited. Subjects will be randomized to receive either a laparotomy or peritoneal drainage. Primary outcome is impairment-free survival 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 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 draina
Sponsor: NICHD Neonatal Research Network

Current Primary Outcome: Death or neurodevelopmental impairment [ Time Frame: Up to 18-22 months corrected age ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Surgical complications [ Time Frame: Up to 18-22 months corrected age ]
  • Number of surgical procedures [ Time Frame: Up to 18-22 months corrected age ]
  • Sepsis episodes [ Time Frame: Up to 18-22 months corrected age ]
  • Duration of parenteral nutrition [ Time Frame: Up to 18-22 months corrected age ]
  • Parenteral nutrition associated cholestasis [ Time Frame: Up to 18-22 months corrected age ]
  • Length of hospital stay [ Time Frame: Until hospital discharge ]
  • Rehospitalizations [ Time Frame: Up to 18-22 months corrected age ]


Original Secondary Outcome: Same as current

Information By: NICHD Neonatal Research Network

Dates:
Date Received: December 9, 2009
Date Started: January 2010
Date Completion: November 2018
Last Updated: September 20, 2016
Last Verified: September 2016