N/A
N=529
Laparotomy vs. Drainage for Infants With Necrotizing Enterocolitis
Infant, Newborn · Infant, Low Birth Weight · Infant, Small for Gestational Age · Infant, Premature · Enterocolitis, Necrotizing
Bottom Line
View on ClinicalTrials.gov: NCT01029353 ↗Enrolled (actual)
529
Serious AEs
37.8%
Results posted
Nov 2021
Primary outcome: Primary: Death or Neurodevelopmental Impairment (NDI) — 44; 46; 27; 28 Participants — p=0.03
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Laparotomy (Procedure); Drainage (Procedure)
- Age
- Pediatric
- Sex
- All
- Sponsor
- NICHD Neonatal Research Network
- Primary completion
- Aug 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Death or Neurodevelopmental Impairment (NDI) |
44; 46; 27; 28; 97; 108 | 0.03 sig |
| SECONDARY Death |
105; 114; 41; 48 | — |
| SECONDARY Survival With Neurodevelopmental Impairment (NDI) |
44; 46; 56; 60 | — |
| SECONDARY Death or Moderate to Severe Cerebral Palsy |
84; 78; 58; 79 | — |
| SECONDARY Death or Bayley Cognitive Composite Score Less Than 85 |
46; 51; 95; 100 | — |
| SECONDARY Death or Blindness |
101; 105; 41; 52 | — |
| SECONDARY Death or Hearing Loss |
98; 105; 43; 51 | — |
| SECONDARY Subsequent Laparotomy |
110; 81; 35; 81 | — |
| SECONDARY Any Intraoperative Complications During Any Surgery |
116; 141; 29; 21 | — |
| SECONDARY Any Wound Dehiscence |
135; 154; 11; 8 | — |
| SECONDARY Any Intra-abdominal Abscess |
141; 158; 5; 4 | — |
| SECONDARY Any Intestinal Stricture |
139; 153; 7; 9 | — |
| SECONDARY Any Late Onset Sepsis |
123; 126; 23; 34 | — |
| SECONDARY Any Parenteral Nutrition (PN)-Associated Cholestasis |
110; 116; 36; 46 | — |
| SECONDARY Any Severe IVH |
122; 132; 18; 25 | — |
| SECONDARY Duration of Mechanical Ventilation |
33.3; 38.9 | — |
| SECONDARY Duration of Parenteral Nutrition |
55.5; 64.1 | — |
| SECONDARY Final Bowel Length |
74.4; 68.7 | — |
| SECONDARY Time to Full Feeds |
46.9; 50.6 | — |
| SECONDARY Length of Hospital Stay |
101.2; 113.8 | — |
| SECONDARY Death or NDI Stratified by Pre-operative Diagnosis |
31; 38; 68; 64; 13; 8 | — |
| SECONDARY Death Stratified by Pre-operative Diagnosis |
80; 88; 24; 21; 25; 26 | — |
| SECONDARY Survival With Neurodevelopmental Impairment (NDI) Stratified by Pre-operative Diagnosis |
31; 38; 44; 43; 13; 8 | — |
| SECONDARY Death or Moderate to Severe Cerebral Palsy Stratified by Pre-operative Diagnosis |
64; 64; 36; 41; 20; 14 | — |
| SECONDARY Death or Bayley Cognitive Composite Score Less Than 85 Stratified by Pre-operative Diagnosis |
32; 42; 67; 59; 14; 9 | — |
| SECONDARY Death or Blindness Stratified by Pre-operative Diagnosis |
76; 83; 24; 22; 25; 22 | — |
| SECONDARY Death or Hearing Loss Stratified by Pre-operative Diagnosis |
73; 81; 26; 23; 25; 24 | — |
| SECONDARY Subsequent Laparotomy Stratified by Pre-operative Diagnosis |
81; 58; 23; 51; 29; 23 | — |
| SECONDARY Any Intraoperative Complications During Any Surgery Stratified by Pre-operative Diagnosis |
83; 95; 21; 14; 33; 46 | — |
| SECONDARY Any Wound Dehiscence Stratified by Pre-operative Diagnosis |
99; 104; 5; 5; 36; 50 | — |
| SECONDARY Any Intra-abdominal Abscess Stratified by Pre-operative Diagnosis |
101; 106; 3; 3; 40; 52 | — |
| SECONDARY Any Intestinal Stricture Stratified by Pre-operative Diagnosis |
101; 103; 3; 6; 38; 50 | — |
| SECONDARY Any Late Onset Sepsis Stratified by Pre-operative Diagnosis |
88; 80; 16; 27; 35; 46 | — |
| SECONDARY Any Parenteral Nutrition (PN)-Associated Cholestasis Stratified by Pre-operative Diagnosis |
79; 82; 25; 27; 31; 34 | — |
| SECONDARY Any Severe IVH Stratified by Pre-operative Diagnosis |
84; 84; 17; 22; 38; 48 | — |
| SECONDARY Duration of Mechanical Ventilation Stratified by Pre-operative Diagnosis |
34.1; 42.2; 31; 31.7 | — |
| SECONDARY Duration of Parenteral Nutrition Stratified by Pre-operative Diagnosis |
56.3; 63.6; 53.5; 65.3 | — |
| SECONDARY Final Bowel Length Stratified by Pre-operative Diagnosis |
83.1; 74.7; 62.7; 64 | — |
| SECONDARY Time to Full Feeds Stratified by Pre-operative Diagnosis |
52.4; 56.3; 29.6; 32.3 | — |
| SECONDARY Length of Hospital Stay Stratified by Pre-operative Diagnosis |
109.6; 121.3; 80.2; 99.2 | — |
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). 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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01029353). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.