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Completed

NCT Number: NCT01029353

Laparotomy vs. Drainage for Infants With Necrotizing Enterocolitis

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.

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Key information

Conditions

Infant, Newborn Digestive System Diseases Enterocolitis Enterocolitis, Necrotizing Female Urogenital Diseases and Pregnancy Complications Gastroenteritis Gastrointestinal Diseases Infant, Low Birth Weight Infant, Premature Infant, Small for Gestational Age Intestinal Diseases Intestinal Perforation Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

Up to 8 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laparotomy

Procedure

Initial laparotomy will be performed. Standard procedures will be used, including inspection of the bowel with removal of diseased areas, creation of stoma(s), and other procedures deemed indicated by the surgeon.

Drainage

Procedure

Initial drainage will involve placing a Penrose drain in the abdomen.

Other names: Peritoneal drain

Primary outcomes

  1. Death or Neurodevelopmental Impairment (NDI)

    Time frame: at 18-22 months corrected age

    Death or NDI at 18-22 months corrected age

Secondary outcomes

  1. Death

    Time frame: by 18-22 months corrected age

    Death by 18-22 months corrected age

  2. Survival With Neurodevelopmental Impairment (NDI)

    Time frame: by 18-22 months corrected age

    NDI at 18-22 months corrected age (among survivors)

  3. Death or Moderate to Severe Cerebral Palsy

    Time frame: up to the follow-up visit completed within the 18-22 months corrected age window

    Death within 18-22 months corrected age or moderate to severe cerebral palsy at 18-22 months corrected age

  4. Death or Bayley Cognitive Composite Score Less Than 85

    Time frame: up to the follow-up visit completed within the 18-22 months corrected age window

    Death within 18-22 months corrected age or Bayley cognitive composite score less than 85 at 18-22 months corrected age. Higher values of the Bayley cognitive composite score is better than lower values. Normal values are greater than or equal to 85. A moderate value is in the 70-84 range, and a severe value is <70.

  5. Death or Blindness

    Time frame: up to the follow-up visit completed within the 18-22 months corrected age window

    Death within 18-22 months corrected age or blindness at 18-22 months corrected age

  6. Death or Hearing Loss

    Time frame: up to the follow-up visit completed within the 18-22 months corrected age window

    Death within 18-22 months corrected age or hearing loss at 18-22 months corrected age

  7. Subsequent Laparotomy

    Time frame: between initial surgery and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth

    Subsequent laparotomy after initial surgery

  8. Any Intraoperative Complications During Any Surgery

    Time frame: between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth

    Any intraoperative complications during any surgery

  9. Any Wound Dehiscence

    Time frame: between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth

    Any wound dehiscence during any surgery

  10. Any Intra-abdominal Abscess

    Time frame: between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth

    Any intra-abdominal abscess during any surgery

  11. Any Intestinal Stricture

    Time frame: between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth

    Any intestinal stricture during any surgery

  12. Any Late Onset Sepsis

    Time frame: between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth

    Any late onset sepsis after randomization

  13. Any Parenteral Nutrition (PN)-Associated Cholestasis

    Time frame: between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth

    Any Parenteral nutrition (PN)-associated cholestasis during any surgery

  14. Any Severe IVH

    Time frame: between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth

    Any severe IVH ater randomization

  15. Duration of Mechanical Ventilation

    Time frame: between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth

    Duration of mechanical ventilation while on study

  16. Duration of Parenteral Nutrition

    Time frame: between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth

    Duration of parenteral nutrition while on study

  17. Final Bowel Length

    Time frame: between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth

    Final bowel length after last surgery

  18. Time to Full Feeds

    Time frame: between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth

    Time to full feeds while on study

  19. Length of Hospital Stay

    Time frame: from randomization up to 1 year following birth

    Length of hospital stay while on study

  20. Death or NDI Stratified by Pre-operative Diagnosis

    Time frame: at 18-22 months corrected age

    Death or NDI at 18-22 months corrected age. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).

  21. Death Stratified by Pre-operative Diagnosis

    Time frame: by 18-22 months corrected age

    Death within 18-22 months corrected age. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).

  22. Survival With Neurodevelopmental Impairment (NDI) Stratified by Pre-operative Diagnosis

    Time frame: by 18-22 months corrected age

    NDI at 18-22 months corrected age (among survivors). Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).

  23. Death or Moderate to Severe Cerebral Palsy Stratified by Pre-operative Diagnosis

    Time frame: up to the follow-up visit completed within the 18-22 months corrected age window

    Death within 18-22 months corrected age or moderate to severe cerebral palsy at 18-22 months corrected age. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).

  24. Death or Bayley Cognitive Composite Score Less Than 85 Stratified by Pre-operative Diagnosis

    Time frame: up to the follow-up visit completed within the 18-22 months corrected age window

    Death within 18-22 months corrected age or Bayley cognitive composite score less than 85 at 18-22 months corrected age. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP). Higher values of the Bayley cognitive composite score is better than lower values. Normal values are greater than or equal to 85. A moderate value is in the 70-84 range, and a severe value is <70.

  25. Death or Blindness Stratified by Pre-operative Diagnosis

    Time frame: up to the follow-up visit completed within the 18-22 months corrected age window

    Death within 18-22 months corrected age or blindness at 18-22 months corrected age. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).

  26. Death or Hearing Loss Stratified by Pre-operative Diagnosis

    Time frame: up to the follow-up visit completed within the 18-22 months corrected age window

    Death within 18-22 months corrected age or hearing loss at 18-22 months corrected age. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).

  27. Subsequent Laparotomy Stratified by Pre-operative Diagnosis

    Time frame: between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth

    Subsequent laparotomy after initial surgery. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).

  28. Any Intraoperative Complications During Any Surgery Stratified by Pre-operative Diagnosis

    Time frame: between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth

    Any intraoperative complications during any surgery. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).

  29. Any Wound Dehiscence Stratified by Pre-operative Diagnosis

    Time frame: between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth

    Any wound dehiscence during any surgery. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).

  30. Any Intra-abdominal Abscess Stratified by Pre-operative Diagnosis

    Time frame: between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth

    Any intra-abdominal abscess during any surgery. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).

  31. Any Intestinal Stricture Stratified by Pre-operative Diagnosis

    Time frame: between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth

    Any intestinal stricture during any surgery. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).

  32. Any Late Onset Sepsis Stratified by Pre-operative Diagnosis

    Time frame: between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth

    Any late onset sepsis after randomization. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).

  33. Any Parenteral Nutrition (PN)-Associated Cholestasis Stratified by Pre-operative Diagnosis

    Time frame: between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth

    Any Parenteral nutrition (PN)-associated cholestasis during any surgery. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).

  34. Any Severe IVH Stratified by Pre-operative Diagnosis

    Time frame: between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth

    Any severe IVH ater randomization. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).

  35. Duration of Mechanical Ventilation Stratified by Pre-operative Diagnosis

    Time frame: between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth

    Duration of mechanical ventilation while on study. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).

  36. Duration of Parenteral Nutrition Stratified by Pre-operative Diagnosis

    Time frame: between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth

    Duration of parenteral nutrition while on study. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).

  37. Final Bowel Length Stratified by Pre-operative Diagnosis

    Time frame: between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth

    Final bowel length after last surgery. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).

  38. Time to Full Feeds Stratified by Pre-operative Diagnosis

    Time frame: between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth

    Time to full feeds while on study. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).

  39. Length of Hospital Stay Stratified by Pre-operative Diagnosis

    Time frame: from randomization up to 1 year following birth

    Length of hospital stay while on study. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).

Sponsors and collaborators

Lead sponsor

NICHD Neonatal Research Network

Network

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Center for Research Resources (NCRR)

Registry information

Official study 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 Perforation (IP): Outcomes at 18-22 Months Adjusted Age

Acronym: NEST

Important dates

Study start
2010
Primary completion
2019
Study completion
2019
First posted
Dec 10, 2009
Registry last updated
Jul 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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