Infant, NewbornNESTNCT01029353
Laparotomy vs. Drainage for Infants With Necrotizing Enterocolitis
A study testing Laparotomy and Drainage in people with Infant, Newborn and Infant, Low Birth Weight, run by NICHD Neonatal Research Network at 22 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages Up to 8 weeks
- Conditions the study is for
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age
- What is being tested?
- Laparotomy and Drainage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 529 participants
- Where
- 22 sitesUnited States
- Study dates
- Jan 2010to Aug 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 8 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
University of New Mexico
Albuquerque, New Mexico, 87131
Emory University
Atlanta, Georgia, 30303
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Tufts Medical Center
Boston, Massachusetts, 02111
Cincinnati Children's Medical Center
Cincinnati, Ohio, 45267
Case Western Reserve University
Cleveland, Ohio, 44106
Research Institute at Nationwide Children's Hospital
Columbus, Ohio, 43205
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75235
Wayne State University
Detroit, Michigan, 48201
RTI International
Durham, North Carolina, 27705
Duke University
Durham, North Carolina, 27710
University of Texas Health Science Center at Houston
Houston, Texas, 77030
Indiana University
Indianapolis, Indiana, 46202
University of Iowa
Iowa City, Iowa, 52242
Children's Mercy Hospital
Kansas City, Missouri, 64108
University of California - Los Angeles
Los Angeles, California, 90025
Yale University
New Haven, Connecticut, 06504
Stanford University
Palo Alto, California, 94304
Univeristy of Pennsylvania
Philadelphia, Pennsylvania, 19104
Brown University, Women & Infants Hospital of Rhode Island
Providence, Rhode Island, 02905
University of Rochester
Rochester, New York, 14642
University of Utah
Salt Lake City, Utah, 84108
About this study
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 Perforation (IP): Outcomes at 18-22 Months Adjusted Age
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.
Read the detailed 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.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature, Enterocolitis, Necrotizing, Intestinal Perforation
- Being tested
- Laparotomy, Drainage
- Keywords
- NICHD Neonatal Research Network, Very Low Birth Weight (VLBW), Extremely Low Birth Weight (ELBW), Prematurity, Laparotomy, Drainage, Isolated intestinal perforation, Focal intestinal perforation
- Medical subject headings
- Premature Birth, Enterocolitis, Necrotizing, Intestinal Perforation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaparotomyProcedure or surgery
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.
DrainageProcedure or surgery
Also called Peritoneal drain
Initial drainage will involve placing a Penrose drain in the abdomen.
| Study group | Role | What they receive |
|---|---|---|
| Randomized Trial: Laparotomy | Active comparator | Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures. Receives: Procedure: Laparotomy |
| Randomized Trial: Peritoneal drain placement | Active comparator | Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation. Receives: Procedure: Drainage |
| Preference Cohort: Laparotomy | Active comparator | Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures. Receives: Procedure: Laparotomy |
| Preference Cohort: Peritoneal drain placement | Active comparator | Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation. Receives: Procedure: Drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death or Neurodevelopmental Impairment (NDI)
Death or NDI at 18-22 months corrected age
Measured: at 18-22 months corrected age
Secondary outcomes (39)
Death
Death by 18-22 months corrected age
Measured: by 18-22 months corrected age
Survival With Neurodevelopmental Impairment (NDI)
NDI at 18-22 months corrected age (among survivors)
Measured: by 18-22 months corrected age
Death or Moderate to Severe Cerebral Palsy
Death within 18-22 months corrected age or moderate to severe cerebral palsy at 18-22 months corrected age
Measured: up to the follow-up visit completed within the 18-22 months corrected age window
Death or Bayley Cognitive Composite Score Less Than 85
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.
Measured: up to the follow-up visit completed within the 18-22 months corrected age window
Death or Blindness
Death within 18-22 months corrected age or blindness at 18-22 months corrected age
Measured: up to the follow-up visit completed within the 18-22 months corrected age window
Death or Hearing Loss
Death within 18-22 months corrected age or hearing loss at 18-22 months corrected age
Measured: up to the follow-up visit completed within the 18-22 months corrected age window
Subsequent Laparotomy
Subsequent laparotomy after initial surgery
Measured: 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
Any Intraoperative Complications During Any Surgery
Any intraoperative complications during any surgery
Measured: 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
Any wound dehiscence during any surgery
Measured: 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
Any intra-abdominal abscess during any surgery
Measured: 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
Any intestinal stricture during any surgery
Measured: 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
Any late onset sepsis after randomization
Measured: 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
Any Parenteral nutrition (PN)-associated cholestasis during any surgery
Measured: 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
Any severe IVH ater randomization
Measured: 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
Duration of mechanical ventilation while on study
Measured: 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
Duration of parenteral nutrition while on study
Measured: 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
Final bowel length after last surgery
Measured: 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
Time to full feeds while on study
Measured: between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth
Length of Hospital Stay
Length of hospital stay while on study
Measured: from randomization up to 1 year following birth
Death or NDI Stratified by Pre-operative Diagnosis
Death or NDI at 18-22 months corrected age. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).
Measured: at 18-22 months corrected age
Death Stratified by Pre-operative Diagnosis
Death within 18-22 months corrected age. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).
Measured: by 18-22 months corrected age
Survival With Neurodevelopmental Impairment (NDI) Stratified by Pre-operative Diagnosis
NDI at 18-22 months corrected age (among survivors). Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).
Measured: by 18-22 months corrected age
Death or Moderate to Severe Cerebral Palsy Stratified by Pre-operative Diagnosis
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).
Measured: up to the follow-up visit completed within the 18-22 months corrected age window
Death or Bayley Cognitive Composite Score Less Than 85 Stratified by Pre-operative Diagnosis
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.
Measured: up to the follow-up visit completed within the 18-22 months corrected age window
Death or Blindness Stratified by Pre-operative Diagnosis
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).
Measured: up to the follow-up visit completed within the 18-22 months corrected age window
Death or Hearing Loss Stratified by Pre-operative Diagnosis
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).
Measured: up to the follow-up visit completed within the 18-22 months corrected age window
Subsequent Laparotomy Stratified by Pre-operative Diagnosis
Subsequent laparotomy after initial surgery. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).
Measured: 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 Stratified by Pre-operative Diagnosis
Any intraoperative complications during any surgery. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).
Measured: 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 Stratified by Pre-operative Diagnosis
Any wound dehiscence during any surgery. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).
Measured: 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 Stratified by Pre-operative Diagnosis
Any intra-abdominal abscess during any surgery. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).
Measured: 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 Stratified by Pre-operative Diagnosis
Any intestinal stricture during any surgery. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).
Measured: 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 Stratified by Pre-operative Diagnosis
Any late onset sepsis after randomization. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).
Measured: 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 Stratified by Pre-operative Diagnosis
Any Parenteral nutrition (PN)-associated cholestasis during any surgery. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).
Measured: 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 Stratified by Pre-operative Diagnosis
Any severe IVH ater randomization. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).
Measured: 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 Stratified by Pre-operative Diagnosis
Duration of mechanical ventilation while on study. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).
Measured: 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 Stratified by Pre-operative Diagnosis
Duration of parenteral nutrition while on study. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).
Measured: 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 Stratified by Pre-operative Diagnosis
Final bowel length after last surgery. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).
Measured: 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 Stratified by Pre-operative Diagnosis
Time to full feeds while on study. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).
Measured: between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth
Length of Hospital Stay Stratified by Pre-operative Diagnosis
Length of hospital stay while on study. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).
Measured: from randomization up to 1 year following birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2009 (estimated)
- Study startJan 2010
- Primary completionAug 2019
- Study completionAug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infant, NewbornStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 529 participants (actual)
Sponsor and investigators
- Lead sponsor
- NICHD Neonatal Research Network
- Sponsor type
- Research network
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Center for Research Resources (NCRR)
- Responsible party
- Sponsor
- Investigators
- Abbot R. Laptook, MD, Principal investigator, Brown University, Women & Infants Hospital of Rhode IslandMichele C. Walsh, MD MS, Principal investigator, Case Western Reserve University, Rainbow Babies and Children's HospitalC. Michael Cotten, MD, Principal investigator, Duke UniversityDavid Carlton, MD, Principal investigator, Emory UniversityGreg Sokol, MD, Principal investigator, Indiana UniversityAbhik Das, PhD, Principal investigator, RTI InternationalKrisa P. Van Meurs, MD, Principal investigator, Stanford UniversityIvan D. Frantz III, MD, Principal investigator, Tufts Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01029353
- Sponsor's protocol ID
- NICHD-NRN-0039
- Other IDs
- U10HD021364, U10HD021373, U10HD021385, U10HD027851, U10HD027853, U10HD027856, U10HD027871, U10HD027880
- Acronym
- NEST
- Status last verified
- Jul 2024
- First submitted
- 9 Dec 2009
- Last updated
- 18 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Rysavy MA, Eggleston B, Dahabreh IJ, Tyson JE, Patel RM, Watterberg KL, Greenberg RG, Pedroza C, Trotta M, Stevenson DK, Stoll BJ, Lally KP, Das A, Blakely ML; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Generalizability of the Necrotizing Enterocolitis Surgery Trial to the Target Population of Eligible Infants. J Pediatr. 2023 Nov;262:113453. doi: 10.1016/j.jpeds.2023.113453. Epub 2023 May 9.
PubMed 37169336
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 Perforation (IP): Outcomes at 18-22 Months Adjusted Age
- ClinicalTrials.gov ID
- NCT01029353
- Acronym / sponsor ID
- NEST / NICHD-NRN-0039
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature, Enterocolitis, Necrotizing, Intestinal Perforation
- Keywords
- NICHD Neonatal Research Network, Very Low Birth Weight (VLBW), Extremely Low Birth Weight (ELBW), Prematurity, Laparotomy, Drainage, Isolated intestinal perforation, Focal intestinal perforation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 529 participants (actual)
- Lead sponsor
- NICHD Neonatal Research NetworkResearch network
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Center for Research Resources (NCRR)
- Study start
- Jan 2010 (actual)
- Primary completion
- Aug 2019 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 10 Dec 2009 (estimated)
- Results
- Posted 23 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Randomized Trial: Laparotomy | Active comparator | Procedure: LaparotomyUnder general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures. |
| Randomized Trial: Peritoneal drain placement | Active comparator | Procedure: DrainagePlace a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation. |
| Preference Cohort: Laparotomy | Active comparator | Procedure: LaparotomyUnder general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures. |
| Preference Cohort: Peritoneal drain placement | Active comparator | Procedure: DrainagePlace a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation. |
Who may qualify
- Ages
- Up to 8 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LaparotomyInitial 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. | Procedure or surgery | Preference Cohort: Laparotomy, Randomized Trial: Laparotomy |
| DrainageAlso: Peritoneal drainInitial drainage will involve placing a Penrose drain in the abdomen. | Procedure or surgery | Preference Cohort: Peritoneal drain placement, Randomized Trial: Peritoneal drain placement |
Primary outcome
Death or Neurodevelopmental Impairment (NDI)
Time frame: at 18-22 months corrected age
Death or NDI at 18-22 months corrected age
39 secondary outcomes
Death
Time frame: by 18-22 months corrected age
Survival With Neurodevelopmental Impairment (NDI)
Time frame: by 18-22 months corrected age
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 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 or Blindness
Time frame: up to the follow-up visit completed within the 18-22 months corrected age window
Death or Hearing Loss
Time frame: up to the follow-up visit completed within the 18-22 months corrected age window
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
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 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 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 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 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 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 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
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 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
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
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
Length of Hospital Stay
Time frame: from randomization up to 1 year following birth
Death or NDI Stratified by Pre-operative Diagnosis
Time frame: at 18-22 months corrected age
Death Stratified by Pre-operative Diagnosis
Time frame: by 18-22 months corrected age
Survival With Neurodevelopmental Impairment (NDI) Stratified by Pre-operative Diagnosis
Time frame: by 18-22 months corrected age
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 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 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 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
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
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 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 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 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 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 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 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
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 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
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
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
Length of Hospital Stay Stratified by Pre-operative Diagnosis
Time frame: from randomization up to 1 year following birth
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37169336Rysavy MA, Eggleston B, Dahabreh IJ, Tyson JE, Patel RM, Watterberg KL, Greenberg RG, Pedroza C, Trotta M, Stevenson DK, Stoll BJ, Lally KP, Das A, Blakely ML; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Generalizability of the Necrotizing Enterocolitis Surgery Trial to the Target Population of Eligible Infants. J Pediatr. 2023 Nov;262:113453. doi: 10.1016/j.jpeds.2023.113453. Epub 2023 May 9.
- NICHD Neonatal Research NetworkLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abbot R. Laptook, MD principal investigator
Brown University, Women & Infants Hospital of Rhode Island
Michele C. Walsh, MD MS principal investigator
Case Western Reserve University, Rainbow Babies and Children's Hospital
C. Michael Cotten, MD principal investigator
Duke University
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparotomy and Drainage in people with Infant, Newborn and Infant, Low Birth Weight, run by NICHD Neonatal Research Network at 22 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death or Neurodevelopmental Impairment (NDI) (time frame: at 18-22 months corrected age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01029353, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2024; AzTrials last refreshed its copy on 26 Oct 2026.