An interventional study of Laparotomy and Drainage in Infant, Newborn, Infant, Low Birth Weight and Infant, Small for Gestational Age, sponsored by NICHD Neonatal Research Network. Completed at 22 sites in United States. Open to participants aged Up to 8 Weeks. Per ClinicalTrials.gov, last updated 2024-07-18.
Sponsored by NICHD Neonatal Research Network · Not applicable, Interventional, and Treatment
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.
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.
2,550 studies on the registry are indexed under Premature Birth; 500 are open to participants now.
This study's enrollment of 529 is above the median of 84 across 1,666 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →NICHD Neonatal Research Network is the lead sponsor of 63 studies on the registry; 5 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 7 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
Procedure: Laparotomy
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
Procedure: Drainage
Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures.
Procedure: Laparotomy
Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation.
Procedure: Drainage
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.
Initial drainage will involve placing a Penrose drain in the abdomen.
Also known as: Peritoneal drain
Death or Neurodevelopmental Impairment (NDI)
Death or NDI at 18-22 months corrected age
Time frame: at 18-22 months corrected age
Death
Death by 18-22 months corrected age
Time frame: by 18-22 months corrected age
Survival With Neurodevelopmental Impairment (NDI)
NDI at 18-22 months corrected age (among survivors)
Time frame: 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
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
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.
Time frame: 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
Time frame: 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
Time frame: up to the follow-up visit completed within the 18-22 months corrected age window
Subsequent Laparotomy
Subsequent laparotomy after initial surgery
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
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
Any wound dehiscence 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 Intra-abdominal Abscess
Any intra-abdominal abscess 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 Intestinal Stricture
Any intestinal stricture 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 Late Onset Sepsis
Any late onset sepsis after randomization
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
Any Parenteral nutrition (PN)-associated cholestasis 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 Severe IVH
Any severe IVH ater randomization
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
Duration of mechanical ventilation while on study
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
Duration of parenteral nutrition while on study
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
Final bowel length after last 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
Time to Full Feeds
Time to full feeds while on study
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
Length of hospital stay while on study
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
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
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.
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
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).
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
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).
Time frame: 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).
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
Any intraoperative complications during any surgery. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).
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
Any wound dehiscence during any surgery. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).
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
Any intra-abdominal abscess during any surgery. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).
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
Any intestinal stricture during any surgery. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).
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
Any late onset sepsis after randomization. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).
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
Any Parenteral nutrition (PN)-associated cholestasis during any surgery. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).
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
Any severe IVH ater randomization. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).
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
Duration of mechanical ventilation while on study. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).
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
Duration of parenteral nutrition while on study. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).
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
Final bowel length after last surgery. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).
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 to full feeds while on study. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).
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
Length of hospital stay while on study. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).
Time frame: from randomization up to 1 year following birth
| Milestone | Randomized Trial: Initial Laparotomy | Randomized Trial: Initial Peritoneal Drain | Preference Cohort: Initial Laparotomy | Preference Cohort: Initial Peritoneal Drain |
|---|---|---|---|---|
| Started | 148 | 162 | 100 | 119 |
| Included in itt analysis | 146 | 162 | 100 | 119 |
| Reached network status | 146 | 162 | 100 | 119 |
| Completed | 141 | 154 | 93 | 115 |
| Not completed | 7 | 8 | 7 | 4 |
| Withdrew: Lost to follow-up | 4 | 5 | 5 | 4 |
| Withdrew: Consent withdrawn | 2 | 0 | 0 | 0 |
| Withdrew: Primary outcome indeterminate | 1 | 3 | 2 | 0 |
Death or NDI at 18-22 months corrected age
| Participants | Randomized Trial: Initial Laparotomy | Randomized Trial: Initial Peritoneal Drain | Preference Cohort: Laparotomy | Preference Cohort: Initial Peritoneal Drain |
|---|---|---|---|---|
| No | 44 | 46 | 27 | 28 |
| Yes | 97 | 108 | 66 | 87 |
Death by 18-22 months corrected age
| Participants | Randomized Trial: Initial Laparotomy | Randomized Trial: Initial Peritoneal Drain |
|---|---|---|
| No | 105 | 114 |
| Yes | 41 | 48 |
NDI at 18-22 months corrected age (among survivors)
| Participants | Randomized Trial: Initial Laparotomy | Randomized Trial: Initial Peritoneal Drain |
|---|---|---|
| No | 44 | 46 |
| Yes | 56 | 60 |
Death within 18-22 months corrected age or moderate to severe cerebral palsy at 18-22 months corrected age
| Participants | Randomized Trial: Initial Laparotomy | Randomized Trial: Initial Peritoneal Drain |
|---|---|---|
| No | 84 | 78 |
| Yes | 58 | 79 |
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.
| Participants | Randomized Trial: Initial Laparotomy | Randomized Trial: Initial Peritoneal Drain |
|---|---|---|
| No | 46 | 51 |
| Yes | 95 | 100 |
Death within 18-22 months corrected age or blindness at 18-22 months corrected age
| Participants | Randomized Trial: Initial Laparotomy | Randomized Trial: Initial Peritoneal Drain |
|---|---|---|
| No | 101 | 105 |
| Yes | 41 | 52 |
Death within 18-22 months corrected age or hearing loss at 18-22 months corrected age
| Participants | Randomized Trial: Initial Laparotomy | Randomized Trial: Initial Peritoneal Drain |
|---|---|---|
| No | 98 | 105 |
| Yes | 43 | 51 |
Subsequent laparotomy after initial surgery
| Participants | Randomized Trial: Initial Laparotomy | Randomized Trial: Initial Peritoneal Drain |
|---|---|---|
| No | 110 | 81 |
| Yes | 35 | 81 |
Any intraoperative complications during any surgery
| Participants | Randomized Trial: Initial Laparotomy | Randomized Trial: Initial Peritoneal Drain |
|---|---|---|
| No | 116 | 141 |
| Yes | 29 | 21 |
Any wound dehiscence during any surgery
| Participants | Randomized Trial: Initial Laparotomy | Randomized Trial: Initial Peritoneal Drain |
|---|---|---|
| No | 135 | 154 |
| Yes | 11 | 8 |
Any intra-abdominal abscess during any surgery
| Participants | Randomized Trial: Initial Laparotomy | Randomized Trial: Initial Peritoneal Drain |
|---|---|---|
| No | 141 | 158 |
| Yes | 5 | 4 |
Any intestinal stricture during any surgery
| Participants | Randomized Trial: Initial Laparotomy | Randomized Trial: Initial Peritoneal Drain |
|---|---|---|
| No | 139 | 153 |
| Yes | 7 | 9 |
Any late onset sepsis after randomization
| Participants | Randomized Trial: Initial Laparotomy | Randomized Trial: Initial Peritoneal Drain |
|---|---|---|
| No | 123 | 126 |
| Yes | 23 | 34 |
Any Parenteral nutrition (PN)-associated cholestasis during any surgery
| Participants | Randomized Trial: Initial Laparotomy | Randomized Trial: Initial Peritoneal Drain |
|---|---|---|
| No | 110 | 116 |
| Yes | 36 | 46 |
Any severe IVH ater randomization
| Participants | Randomized Trial: Initial Laparotomy | Randomized Trial: Initial Peritoneal Drain |
|---|---|---|
| No | 122 | 132 |
| Yes | 18 | 25 |
Duration of mechanical ventilation while on study
| days | Randomized Trial: Initial Laparotomy | Randomized Trial: Initial Peritoneal Drain |
|---|---|---|
| Duration of Mechanical Ventilation | 33.3 ± 25.6 | 38.9 ± 26.7 |
Duration of parenteral nutrition while on study
| days | Randomized Trial: Initial Laparotomy | Randomized Trial: Initial Peritoneal Drain |
|---|---|---|
| Duration of Parenteral Nutrition | 55.5 ± 34.1 | 64.1 ± 36.4 |
Final bowel length after last surgery
| cm | Randomized Trial: Initial Laparotomy | Randomized Trial: Initial Peritoneal Drain |
|---|---|---|
| Final Bowel Length | 74.4 ± 24.6 | 68.7 ± 35.7 |
Time to full feeds while on study
| days | Randomized Trial: Initial Laparotomy | Randomized Trial: Initial Peritoneal Drain |
|---|---|---|
| Time to Full Feeds | 46.9 ± 45.8 | 50.6 ± 27.7 |
Length of hospital stay while on study
| days | Randomized Trial: Initial Laparotomy | Randomized Trial: Initial Peritoneal Drain |
|---|---|---|
| Length of Hospital Stay | 101.2 ± 71.2 | 113.8 ± 73.8 |
Death or NDI at 18-22 months corrected age. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).
| Participants | Randomized Trial: Initial Laparotomy | Randomized Trial: Initial Peritoneal Drain |
|---|---|---|
| IP — No | 31 | 38 |
| IP — Yes | 68 | 64 |
| NEC — No | 13 | 8 |
| NEC — Yes | 29 | 44 |
Death within 18-22 months corrected age. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).
| Participants | Randomized Trial: Initial Laparotomy | Randomized Trial: Initial Peritoneal Drain |
|---|---|---|
| IP — No | 80 | 88 |
| IP — Yes | 24 | 21 |
| NEC — No | 25 | 26 |
| NEC — Yes | 17 | 27 |
NDI at 18-22 months corrected age (among survivors). Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).
| Participants | Randomized Trial: Initial Laparotomy | Randomized Trial: Initial Peritoneal Drain |
|---|---|---|
| IP — No | 31 | 38 |
| IP — Yes | 44 | 43 |
| NEC — No | 13 | 8 |
| NEC — Yes | 12 | 17 |
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).
| Participants | Randomized Trial: Initial Laparotomy | Randomized Trial: Initial Peritoneal Drain |
|---|---|---|
| IP — No | 64 | 64 |
| IP — Yes | 36 | 41 |
| NEC — No | 20 | 14 |
| NEC — Yes | 22 | 38 |
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.
| Participants | Randomized Trial: Initial Laparotomy | Randomized Trial: Initial Peritoneal Drain |
|---|---|---|
| IP — No | 32 | 42 |
| IP — Yes | 67 | 59 |
| NEC — No | 14 | 9 |
| NEC — Yes | 28 | 41 |
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).
| Participants | Randomized Trial: Initial Laparotomy | Randomized Trial: Initial Peritoneal Drain |
|---|---|---|
| IP — No | 76 | 83 |
| IP — Yes | 24 | 22 |
| NEC — No | 25 | 22 |
| NEC — Yes | 17 | 30 |
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).
| Participants | Randomized Trial: Initial Laparotomy | Randomized Trial: Initial Peritoneal Drain |
|---|---|---|
| IP — No | 73 | 81 |
| IP — Yes | 26 | 23 |
| NEC — No | 25 | 24 |
| NEC — Yes | 17 | 28 |
Subsequent laparotomy after initial surgery. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).
| Participants | Randomized Trial: Initial Laparotomy | Randomized Trial: Initial Peritoneal Drain |
|---|---|---|
| IP — No | 81 | 58 |
| IP — Yes | 23 | 51 |
| NEC — No | 29 | 23 |
| NEC — Yes | 12 | 30 |
Any intraoperative complications during any surgery. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).
| Participants | Randomized Trial: Initial Laparotomy | Randomized Trial: Initial Peritoneal Drain |
|---|---|---|
| IP — No | 83 | 95 |
| IP — Yes | 21 | 14 |
| NEC — No | 33 | 46 |
| NEC — Yes | 8 | 7 |
Any wound dehiscence during any surgery. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).
| Participants | Randomized Trial: Initial Laparotomy | Randomized Trial: Initial Peritoneal Drain |
|---|---|---|
| IP — No | 99 | 104 |
| IP — Yes | 5 | 5 |
| NEC — No | 36 | 50 |
| NEC — Yes | 6 | 3 |
Any intra-abdominal abscess during any surgery. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).
| Participants | Randomized Trial: Initial Laparotomy | Randomized Trial: Initial Peritoneal Drain |
|---|---|---|
| IP — No | 101 | 106 |
| IP — Yes | 3 | 3 |
| NEC — No | 40 | 52 |
| NEC — Yes | 2 | 1 |
Any intestinal stricture during any surgery. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).
| Participants | Randomized Trial: Initial Laparotomy | Randomized Trial: Initial Peritoneal Drain |
|---|---|---|
| IP — No | 101 | 103 |
| IP — Yes | 3 | 6 |
| NEC — No | 38 | 50 |
| NEC — Yes | 4 | 3 |
Any late onset sepsis after randomization. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).
| Participants | Randomized Trial: Initial Laparotomy | Randomized Trial: Initial Peritoneal Drain |
|---|---|---|
| IP — No | 88 | 80 |
| IP — Yes | 16 | 27 |
| NEC — No | 35 | 46 |
| NEC — Yes | 7 | 7 |
Any Parenteral nutrition (PN)-associated cholestasis during any surgery. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).
| Participants | Randomized Trial: Initial Laparotomy | Randomized Trial: Initial Peritoneal Drain |
|---|---|---|
| IP — No | 79 | 82 |
| IP — Yes | 25 | 27 |
| NEC — No | 31 | 34 |
| NEC — Yes | 11 | 19 |
Any severe IVH ater randomization. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).
| Participants | Randomized Trial: Initial Laparotomy | Randomized Trial: Initial Peritoneal Drain |
|---|---|---|
| IP — No | 84 | 84 |
| IP — Yes | 17 | 22 |
| NEC — No | 38 | 48 |
| NEC — Yes | 1 | 3 |
Duration of mechanical ventilation while on study. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).
| days | Randomized Trial: Initial Laparotomy | Randomized Trial: Initial Peritoneal Drain |
|---|---|---|
| IP | 34.1 ± 26.6 | 42.2 ± 28 |
| NEC | 31 ± 22.6 | 31.7 ± 22.5 |
Duration of parenteral nutrition while on study. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).
| days | Randomized Trial: Initial Laparotomy | Randomized Trial: Initial Peritoneal Drain |
|---|---|---|
| IP | 56.3 ± 35.2 | 63.6 ± 33.7 |
| NEC | 53.5 ± 31.3 | 65.3 ± 42 |
Final bowel length after last surgery. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).
| cm | Randomized Trial: Initial Laparotomy | Randomized Trial: Initial Peritoneal Drain |
|---|---|---|
| IP | 83.1 ± 20.9 | 74.7 ± 22.4 |
| NEC | 62.7 ± 25 | 64 ± 44.2 |
Time to full feeds while on study. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).
| days | Randomized Trial: Initial Laparotomy | Randomized Trial: Initial Peritoneal Drain |
|---|---|---|
| IP | 52.4 ± 50.4 | 56.3 ± 27.1 |
| NEC | 29.6 ± 18.9 | 32.3 ± 21.3 |
Length of hospital stay while on study. Stratification variable is pre-operative diagnosis: Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP).
| days | Randomized Trial: Initial Laparotomy | Randomized Trial: Initial Peritoneal Drain |
|---|---|---|
| IP | 109.6 ± 67 | 121.3 ± 64.7 |
| NEC | 80.2 ± 77.8 | 99.2 ± 87.7 |
Collected over Adverse events are monitored from randomization through study status (death, discharge or 120 days). Non-serious events are listed at a 0.00% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Randomized Trial: Initial Laparotomy | 41/146 (28.1%) | 41/146 (28.1%) | 0/146 (0%) |
| Randomized Trial: Initial Peritoneal Drain | 48/162 (29.6%) | 49/162 (30.2%) | 0/162 (0%) |
| Preference Cohort: Initial Laparotomy | 48/100 (48%) | 49/100 (49%) | 0/100 (0%) |
| Preference Cohort: Initial Peritoneal Drain | 60/119 (50.4%) | 60/119 (50.4%) | 0/119 (0%) |
| Event | Randomized Trial: Initial Laparotomy | Randomized Trial: Initial Peritoneal Drain | Preference Cohort: Initial Laparotomy | Preference Cohort: Initial Peritoneal Drain |
|---|---|---|---|---|
| Necrotizing enterocolitis neonatalGastrointestinal disorders | 21/146 | 24/162 | 35/100 | 25/119 |
| Neonatal sepsisInfections and infestations | 10/146 | 16/162 | 13/100 | 9/119 |
| Neonatal spontaneous intestinal perforationGastrointestinal disorders | 3/146 | 0/162 | 2/100 | 9/119 |
| DeathGeneral disorders | 4/146 | 11/162 | 6/100 | 8/119 |
| Neonatal respiratory distress syndromeRespiratory, thoracic and mediastinal disorders | 3/146 | 1/162 | 0/100 | 7/119 |
| Neonatal infectionInfections and infestations | 1/146 | 2/162 | 0/100 | 7/119 |
| Intracranial hemorrhageNervous system disorders | 4/146 | 1/162 | 0/100 | 3/119 |
| PrematurityPregnancy, puerperium and perinatal conditions | 3/146 | 1/162 | 0/100 | 2/119 |
| Bronchopulmonary dysplasiaRespiratory, thoracic and mediastinal disorders | 1/146 | 2/162 | 1/100 | 2/119 |
| Cardiopulmonary failureCardiac disorders | 0/146 | 1/162 | 0/100 | 2/119 |
| Age, Continuous(days) | Randomized Trial: Initial Laparotomy | Randomized Trial: Initial Peritoneal Drain | Preference Cohort: Initial Laparotomy | Preference Cohort: Initial Peritoneal Drain | Total |
|---|---|---|---|---|---|
| Mean | 11.6 ± 10 | 12.1 ± 9.9 | 79.9 ± 125.4 | 49.9 ± 111.7 | 33.3 ± 81.0 |
| Sex/Gender, Customized(Participants) | Randomized Trial: Initial Laparotomy | Randomized Trial: Initial Peritoneal Drain | Preference Cohort: Initial Laparotomy | Preference Cohort: Initial Peritoneal Drain | Total |
|---|---|---|---|---|---|
| Female | 66 | 63 | 48 | 53 | 230 |
| Male | 80 | 98 | 52 | 66 | 296 |
| Missing | 0 | 1 | 0 | 0 | 1 |
| Race/Ethnicity, Customized(Participants) | Randomized Trial: Initial Laparotomy | Randomized Trial: Initial Peritoneal Drain | Preference Cohort: Initial Laparotomy | Preference Cohort: Initial Peritoneal Drain | Total |
|---|---|---|---|---|---|
| Black | 62 | 67 | 31 | 42 | 202 |
| Missing | 5 | 5 | 1 | 1 | 12 |
| Other | 6 | 8 | 9 | 6 | 29 |
| White | 73 | 82 | 59 | 70 | 284 |
| Maternal hispanic ethnicity(Participants) | Randomized Trial: Initial Laparotomy | Randomized Trial: Initial Peritoneal Drain | Preference Cohort: Initial Laparotomy | Preference Cohort: Initial Peritoneal Drain | Total |
|---|---|---|---|---|---|
| Missing | 1 | 9 | 3 | 9 | 22 |
| No | 107 | 120 | 75 | 95 | 397 |
| Yes | 38 | 33 | 22 | 15 | 108 |
| Infant gestational age(weeks) | Randomized Trial: Initial Laparotomy | Randomized Trial: Initial Peritoneal Drain | Preference Cohort: Initial Laparotomy | Preference Cohort: Initial Peritoneal Drain | Total |
|---|---|---|---|---|---|
| Mean | 25 ± 1.7 | 24.9 ± 1.7 | 24.6 ± 1.1 | 24.5 ± 1.2 | 25 ± 1.7 |
| Infant birth weight(gram) | Randomized Trial: Initial Laparotomy | Randomized Trial: Initial Peritoneal Drain | Preference Cohort: Initial Laparotomy | Preference Cohort: Initial Peritoneal Drain | Total |
|---|---|---|---|---|---|
| Mean | 721.2 ± 138.4 | 711.4 ± 135.9 | 719.8 ± 150.5 | 675.6 ± 161.7 | 707.6 ± 146.2 |
| Infant was small for gestational age(Participants) | Randomized Trial: Initial Laparotomy | Randomized Trial: Initial Peritoneal Drain | Preference Cohort: Initial Laparotomy | Preference Cohort: Initial Peritoneal Drain | Total |
|---|---|---|---|---|---|
| Missing | 0 | 1 | 0 | 0 | 1 |
| No | 131 | 145 | 84 | 98 | 458 |
| Yes | 15 | 16 | 16 | 21 | 68 |
| Inborn status(Participants) | Randomized Trial: Initial Laparotomy | Randomized Trial: Initial Peritoneal Drain | Preference Cohort: Initial Laparotomy | Preference Cohort: Initial Peritoneal Drain | Total |
|---|---|---|---|---|---|
| In born | 82 | 90 | 65 | 75 | 312 |
| Out born | 64 | 72 | 35 | 44 | 215 |
27 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
NICHD Neonatal Research Network