Laparotomy vs. Drainage for Infants With Necrotizing Enterocolitis (NEST)

N

NICHD Neonatal Research Network

Status

Completed

Conditions

Infant, Low Birth Weight
Infant, Newborn
Intestinal Perforation
Infant, Small for Gestational Age
Enterocolitis, Necrotizing
Infant, Premature

Treatments

Procedure: Drainage
Procedure: Laparotomy

Study type

Interventional

Funder types

NETWORK
NIH

Identifiers

NCT01029353
U10HD053109 (U.S. NIH Grant/Contract)
UL1RR024979 (U.S. NIH Grant/Contract)
U10HD068270 (U.S. NIH Grant/Contract)
U10HD021364 (U.S. NIH Grant/Contract)
UL1RR025764 (U.S. NIH Grant/Contract)
U10HD027880 (U.S. NIH Grant/Contract)
U10HD036790 (U.S. NIH Grant/Contract)
U10HD027856 (U.S. NIH Grant/Contract)
U10HD053089 (U.S. NIH Grant/Contract)
NICHD-NRN-0039
U10HD027851 (U.S. NIH Grant/Contract)
U10HD068244 (U.S. NIH Grant/Contract)
U10HD040689 (U.S. NIH Grant/Contract)
UG1HD087226 (U.S. NIH Grant/Contract)
M01RR008084 (U.S. NIH Grant/Contract)
U10HD068278 (U.S. NIH Grant/Contract)
U10HD027871 (U.S. NIH Grant/Contract)
UL1RR024139 (U.S. NIH Grant/Contract)
U10HD021373 (U.S. NIH Grant/Contract)
U10HD027853 (U.S. NIH Grant/Contract)
U10HD053119 (U.S. NIH Grant/Contract)
UL1RR025744 (U.S. NIH Grant/Contract)
U10HD040492 (U.S. NIH Grant/Contract)
UL1RR025777 (U.S. NIH Grant/Contract)
U10HD053124 (U.S. NIH Grant/Contract)
U10HD068284 (U.S. NIH Grant/Contract)
U10HD068263 (U.S. NIH Grant/Contract)
U10HD034216 (U.S. NIH Grant/Contract)
U10HD021385 (U.S. NIH Grant/Contract)
U10HD027904 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This study 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.

Full description

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 included 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 study also attempted to use a comprehensive cohort design that would have added additional information beyond the conventional randomized trial component. The cohort component included trial data among eligible, non-randomized infants with NEC/IP, who consented for the non-randomized cohort, would be collected and analyzed as a secondary specific aim. This additional cohort was called the preference cohort.

Enrollment

529 patients

Sex

All

Ages

Under 8 weeks old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

529 participants in 4 patient groups

Randomized Trial: Laparotomy
Active Comparator group
Description:
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
Treatment:
Procedure: Laparotomy
Randomized Trial: Peritoneal drain placement
Active Comparator group
Description:
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
Treatment:
Procedure: Drainage
Preference Cohort: Laparotomy
Active Comparator group
Description:
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
Treatment:
Procedure: Laparotomy
Preference Cohort: Peritoneal drain placement
Active Comparator group
Description:
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
Treatment:
Procedure: Drainage

Trial documents
2

Trial contacts and locations

22

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Data sourced from clinicaltrials.gov

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