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

Study ID
STU 102010-164

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • Children's Medical Center-Dallas
  • Parkland Health & Hospital System

Contact
Diana Vasil
214-648-3789
diana.vasil@utsouthwestern.edu

Principal Investigator
Myra Wyckoff

Summary

Concise Summary of Project: This is a multicenter, randomized trial of infants with neC or iP requiring surgical intervention or isolated intestinal perforation. infants will be randomized to either initial laparotomy or drainage, and the primary outcome is death or neuro-developmental impairment at 18-22 months. This study will utilize a comprehensive cohort design that is most often used when the disease is rare or uncommon, and it is difficult to conduct a conventional randomized trial, as in the proposed study. in addition to the randomized cohort, infants whose surgical treatment for neC or iP (laparotomy or drainage) is based on physician or parent preference will be enrolled and studied as a 'preference cohort. This design will help in assessing diagnosis and prognosis, and it may increase the generalizability of results as well as the precision of the treatment comparison. its use is supported by a recent systematic review (JaMa, 2005), particularly for trials designed like ours to minimize bias, prospectively assess and adjust for baseline differences, and verify that that randomized and preference groups have a similar risk-adjusted relative risk for the primary outcome (with laparotomy relative to drainage).The primary outcome variable, is death or neurodevelopmental impairment at 18-22 months as assessed in the generic follow-up of eLBW infants in network centers. The secondary outcomes variables will include surgical complications, such as wound dehiscence, intestinal stricture or fistula, procedure-related liver hemorrhage; number of surgical procedures, sepsis episodes; duration of parenteral nutrition; parenteral nutrition associated cholestasis; length of hospital stay; rehospitalizations each component of the primary outcome.

Participant Eligibility

1) Infants < 1000 grams birth weight
2) A decision by attending pediatric surgeon to perform surgery for suspected NEC or intestinal perforation
3) Infant less or equal to 8 weeks of age (< 8 0/7 wks)
4) Patient is at a Network center able to perform both laparotomy and drainage.