| Primary | Death or Neurodevelopmental Impairment (NDI) | Death or NDI at 18-22 months corrected age | Analysis of randomized trial data included all eligible participants who were consented, randomized, did not withdraw consent, and who provided outcome data after randomization. Analysis of preference cohort data included all eligible participants who were consented, enrolled, did not withdraw consent, and who provided outcome data. | Posted | | Count of Participants | | Participants | | at 18-22 months corrected age | | | | ID | Title | Description |
|---|
| OG000 | Randomized Trial: Initial Laparotomy | Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures. | | OG001 | Randomized Trial: Initial Peritoneal Drain | Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation. | | OG002 | Preference Cohort: Laparotomy | Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures. | | OG003 | Preference Cohort: Initial Peritoneal Drain | Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation. |
| | Units | Counts |
|---|
| Participants | - OG000141
- OG001154
- OG00293
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| No | - OG00044
- OG00146
- OG00227
- OG003
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| A frequentist analysis. Model included treatment, baseline risk of death or NDI, and pre-operative diagnosis (Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP)) as covariates. | | | | | Risk Ratio (RR) | 1.00 | | | 2-Sided | 95 | 0.87 | 1.14 | | | RR: Initial Laparotomy over Peritoneal Drain. RR from robust Poisson regression with log link, reference cell coding, center as repeated measure. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates. | | Superiority | |
|
| Secondary | Death | Death by 18-22 months corrected age | Analysis included all eligible participants who were consented, randomized, did not withdraw consent, and who provided outcome data after randomization. | Posted | | Count of Participants | | Participants | | by 18-22 months corrected age | | | | ID | Title | Description |
|---|
| OG000 | Randomized Trial: Initial Laparotomy | Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures. | | OG001 | Randomized Trial: Initial Peritoneal Drain | Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation. |
| |
| Secondary | Survival With Neurodevelopmental Impairment (NDI) | NDI at 18-22 months corrected age (among survivors) | Analysis included all eligible participants who were consented, randomized, did not withdraw consent, survived until follow-up visit at 18-22 months, and provided sufficient information to determine if NDI occurred. | Posted | | Count of Participants | | Participants | | by 18-22 months corrected age | | | | ID | Title | Description |
|---|
| OG000 | Randomized Trial: Initial Laparotomy | Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures. | | OG001 | Randomized Trial: Initial Peritoneal Drain | Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation. |
| |
| Secondary | 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 | Analysis included all eligible participants who were consented, randomized, did not withdraw consent, and who provided outcome data after randomization. | Posted | | Count of Participants | | Participants | | up to the follow-up visit completed within the 18-22 months corrected age window | | | | ID | Title | Description |
|---|
| OG000 | Randomized Trial: Initial Laparotomy | Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures. | | OG001 | Randomized Trial: Initial Peritoneal Drain | Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation. |
| |
| Secondary | 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. | Analysis included all eligible participants who were consented, randomized, did not withdraw consent, and who provided outcome data after randomization. | Posted | | Count of Participants | | Participants | | up to the follow-up visit completed within the 18-22 months corrected age window | | | | ID | Title | Description |
|---|
| OG000 | Randomized Trial: Initial Laparotomy | Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures. | | OG001 | Randomized Trial: Initial Peritoneal Drain | Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation. |
| |
| Secondary | Death or Blindness | Death within 18-22 months corrected age or blindness at 18-22 months corrected age | Analysis included all eligible participants who were consented, randomized, did not withdraw consent, and who provided outcome data after randomization. | Posted | | Count of Participants | | Participants | | up to the follow-up visit completed within the 18-22 months corrected age window | | | | ID | Title | Description |
|---|
| OG000 | Randomized Trial: Initial Laparotomy | Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures. | | OG001 | Randomized Trial: Initial Peritoneal Drain | Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation. |
| |
| Secondary | Death or Hearing Loss | Death within 18-22 months corrected age or hearing loss at 18-22 months corrected age | Analysis included all eligible participants who were consented, randomized, did not withdraw consent, and who provided outcome data after randomization. | Posted | | Count of Participants | | Participants | | up to the follow-up visit completed within the 18-22 months corrected age window | | | | ID | Title | Description |
|---|
| OG000 | Randomized Trial: Initial Laparotomy | Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures. | | OG001 | Randomized Trial: Initial Peritoneal Drain | Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation. |
| |
| Secondary | Subsequent Laparotomy | Subsequent laparotomy after initial surgery | Analysis included all eligible participants who were consented, randomized, did not withdraw consent, and who provided outcome data after randomization. | Posted | | Count of Participants | | Participants | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Randomized Trial: Initial Laparotomy | Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures. | | OG001 | Randomized Trial: Initial Peritoneal Drain | Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation. |
| |
| Secondary | Any Intraoperative Complications During Any Surgery | Any intraoperative complications during any surgery | Analysis included all eligible participants who were consented, randomized, did not withdraw consent, and who provided outcome data after randomization. | Posted | | Count of Participants | | Participants | | between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth | | | | ID | Title | Description |
|---|
| OG000 | Randomized Trial: Initial Laparotomy | Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures. | | OG001 | Randomized Trial: Initial Peritoneal Drain | Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation. |
| |
| Secondary | Any Wound Dehiscence | Any wound dehiscence during any surgery | Analysis included all eligible participants who were consented, randomized, did not withdraw consent, and who provided outcome data after randomization. | Posted | | Count of Participants | | Participants | | between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth | | | | ID | Title | Description |
|---|
| OG000 | Randomized Trial: Initial Laparotomy | Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures. | | OG001 | Randomized Trial: Initial Peritoneal Drain | Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation. |
| |
| Secondary | Any Intra-abdominal Abscess | Any intra-abdominal abscess during any surgery | Analysis included all eligible participants who were consented, randomized, did not withdraw consent, and who provided outcome data after randomization. | Posted | | Count of Participants | | Participants | | between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth | | | | ID | Title | Description |
|---|
| OG000 | Randomized Trial: Initial Laparotomy | Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures. | | OG001 | Randomized Trial: Initial Peritoneal Drain | Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation. |
| |
| Secondary | Any Intestinal Stricture | Any intestinal stricture during any surgery | Analysis included all eligible participants who were consented, randomized, did not withdraw consent, and who provided outcome data after randomization. | Posted | | Count of Participants | | Participants | | between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth | | | | ID | Title | Description |
|---|
| OG000 | Randomized Trial: Initial Laparotomy | Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures. | | OG001 | Randomized Trial: Initial Peritoneal Drain | Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation. |
| |
| Secondary | Any Late Onset Sepsis | Any late onset sepsis after randomization | Analysis included all eligible participants who were consented, randomized, did not withdraw consent, and who provided outcome data after randomization. | Posted | | Count of Participants | | Participants | | between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth | | | | ID | Title | Description |
|---|
| OG000 | Randomized Trial: Initial Laparotomy | Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures. | | OG001 | Randomized Trial: Initial Peritoneal Drain | Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation. |
| |
| Secondary | Any Parenteral Nutrition (PN)-Associated Cholestasis | Any Parenteral nutrition (PN)-associated cholestasis during any surgery | Analysis included all eligible participants who were consented, randomized, did not withdraw consent, and who provided outcome data after randomization. | Posted | | Count of Participants | | Participants | | between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth | | | | ID | Title | Description |
|---|
| OG000 | Randomized Trial: Initial Laparotomy | Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures. | | OG001 | Randomized Trial: Initial Peritoneal Drain | Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation. |
| |
| Secondary | Any Severe IVH | Any severe IVH ater randomization | Analysis included all eligible participants who were consented, randomized, did not withdraw consent, and who provided outcome data after randomization. | Posted | | Count of Participants | | Participants | | between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth | | | | ID | Title | Description |
|---|
| OG000 | Randomized Trial: Initial Laparotomy | Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures. | | OG001 | Randomized Trial: Initial Peritoneal Drain | Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation. |
| |
| Secondary | Duration of Mechanical Ventilation | Duration of mechanical ventilation while on study | Analysis included all eligible participants who were consented, randomized, did not withdraw consent, and who provided outcome data after randomization. | Posted | | Mean | Standard Deviation | days | | between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth | | | | ID | Title | Description |
|---|
| OG000 | Randomized Trial: Initial Laparotomy | Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures. | | OG001 | Randomized Trial: Initial Peritoneal Drain | Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation. |
| |
| Secondary | Duration of Parenteral Nutrition | Duration of parenteral nutrition while on study | Analysis included all eligible participants who were consented, randomized, did not withdraw consent, and who provided outcome data after randomization. | Posted | | Mean | Standard Deviation | days | | between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth | | | | ID | Title | Description |
|---|
| OG000 | Randomized Trial: Initial Laparotomy | Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures. | | OG001 | Randomized Trial: Initial Peritoneal Drain | Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation. |
| |
| Secondary | Final Bowel Length | Final bowel length after last surgery | Analysis included all eligible participants who were consented, randomized, did not withdraw consent, and who provided outcome data after randomization. | Posted | | Mean | Standard Deviation | cm | | between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth | | | | ID | Title | Description |
|---|
| OG000 | Randomized Trial: Initial Laparotomy | Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures. | | OG001 | Randomized Trial: Initial Peritoneal Drain | Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation. |
| |
| Secondary | Time to Full Feeds | Time to full feeds while on study | Analysis included all eligible participants who were consented, randomized, did not withdraw consent, and who provided outcome data after randomization. | Posted | | Mean | Standard Deviation | days | | between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth | | | | ID | Title | Description |
|---|
| OG000 | Randomized Trial: Initial Laparotomy | Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures. | | OG001 | Randomized Trial: Initial Peritoneal Drain | Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation. |
| |
| Secondary | Length of Hospital Stay | Length of hospital stay while on study | Analysis included all eligible participants who were consented, randomized, did not withdraw consent, and who provided outcome data after randomization. | Posted | | Mean | Standard Deviation | days | | from randomization up to 1 year following birth | | | | ID | Title | Description |
|---|
| OG000 | Randomized Trial: Initial Laparotomy | Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures. | | OG001 | Randomized Trial: Initial Peritoneal Drain | Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation. |
| |
| Secondary | 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). | Analysis included all eligible participants who were consented, randomized, did not withdraw consent, and who provided outcome data after randomization. | Posted | | Count of Participants | | Participants | | at 18-22 months corrected age | | | | ID | Title | Description |
|---|
| OG000 | Randomized Trial: Initial Laparotomy | Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures. | | OG001 | Randomized Trial: Initial Peritoneal Drain | Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation. |
| |
| Secondary | 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). | Analysis included all eligible participants who were consented, randomized, did not withdraw consent, and who provided outcome data after randomization. | Posted | | Count of Participants | | Participants | | by 18-22 months corrected age | | | | ID | Title | Description |
|---|
| OG000 | Randomized Trial: Initial Laparotomy | Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures. | | OG001 | Randomized Trial: Initial Peritoneal Drain | Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation. |
| |
| Secondary | 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). | Analysis included all eligible participants who were consented, randomized, did not withdraw consent, survived until follow-up visit at 18-22 months, and provided sufficient information to determine if NDI occurred. | Posted | | Count of Participants | | Participants | | by 18-22 months corrected age | | | | ID | Title | Description |
|---|
| OG000 | Randomized Trial: Initial Laparotomy | Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures. | | OG001 | Randomized Trial: Initial Peritoneal Drain | Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation. |
| |
| Secondary | 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). | Analysis included all eligible participants who were consented, randomized, did not withdraw consent, and who provided outcome data after randomization. | Posted | | Count of Participants | | Participants | | up to the follow-up visit completed within the 18-22 months corrected age window | | | | ID | Title | Description |
|---|
| OG000 | Randomized Trial: Initial Laparotomy | Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures. | | OG001 | Randomized Trial: Initial Peritoneal Drain | Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation. |
| |
| Secondary | 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. | Analysis included all eligible participants who were consented, randomized, did not withdraw consent, and who provided outcome data after randomization. | Posted | | Count of Participants | | Participants | | up to the follow-up visit completed within the 18-22 months corrected age window | | | | ID | Title | Description |
|---|
| OG000 | Randomized Trial: Initial Laparotomy | Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures. | | OG001 | Randomized Trial: Initial Peritoneal Drain | Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation. |
| |
| Secondary | 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). | Analysis included all eligible participants who were consented, randomized, did not withdraw consent, and who provided outcome data after randomization. | Posted | | Count of Participants | | Participants | | up to the follow-up visit completed within the 18-22 months corrected age window | | | | ID | Title | Description |
|---|
| OG000 | Randomized Trial: Initial Laparotomy | Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures. | | OG001 | Randomized Trial: Initial Peritoneal Drain | Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation. |
| |
| Secondary | 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). | Analysis included all eligible participants who were consented, randomized, did not withdraw consent, and who provided outcome data after randomization. | Posted | | Count of Participants | | Participants | | up to the follow-up visit completed within the 18-22 months corrected age window | | | | ID | Title | Description |
|---|
| OG000 | Randomized Trial: Initial Laparotomy | Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures. | | OG001 | Randomized Trial: Initial Peritoneal Drain | Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation. |
| |
| Secondary | 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). | Analysis included all eligible participants who were consented, randomized, did not withdraw consent, and who provided outcome data after randomization. | Posted | | Count of Participants | | Participants | | between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth | | | | ID | Title | Description |
|---|
| OG000 | Randomized Trial: Initial Laparotomy | Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures. | | OG001 | Randomized Trial: Initial Peritoneal Drain | Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation. |
| |
| Secondary | 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). | Analysis included all eligible participants who were consented, randomized, did not withdraw consent, and who provided outcome data after randomization. | Posted | | Count of Participants | | Participants | | between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth | | | | ID | Title | Description |
|---|
| OG000 | Randomized Trial: Initial Laparotomy | Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures. | | OG001 | Randomized Trial: Initial Peritoneal Drain | Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation. |
| |
| Secondary | 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). | Analysis included all eligible participants who were consented, randomized, did not withdraw consent, and who provided outcome data after randomization. | Posted | | Count of Participants | | Participants | | between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth | | | | ID | Title | Description |
|---|
| OG000 | Randomized Trial: Initial Laparotomy | Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures. | | OG001 | Randomized Trial: Initial Peritoneal Drain | Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation. |
| |
| Secondary | 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). | Analysis included all eligible participants who were consented, randomized, did not withdraw consent, and who provided outcome data after randomization. | Posted | | Count of Participants | | Participants | | between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth | | | | ID | Title | Description |
|---|
| OG000 | Randomized Trial: Initial Laparotomy | Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures. | | OG001 | Randomized Trial: Initial Peritoneal Drain | Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation. |
| |
| Secondary | 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). | Analysis included all eligible participants who were consented, randomized, did not withdraw consent, and who provided outcome data after randomization. | Posted | | Count of Participants | | Participants | | between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth | | | | ID | Title | Description |
|---|
| OG000 | Randomized Trial: Initial Laparotomy | Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures. | | OG001 | Randomized Trial: Initial Peritoneal Drain | Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation. |
| |
| Secondary | 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). | Analysis included all eligible participants who were consented, randomized, did not withdraw consent, and who provided outcome data after randomization. | Posted | | Count of Participants | | Participants | | between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth | | | | ID | Title | Description |
|---|
| OG000 | Randomized Trial: Initial Laparotomy | Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures. | | OG001 | Randomized Trial: Initial Peritoneal Drain | Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation. |
| |
| Secondary | 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). | Analysis included all eligible participants who were consented, randomized, did not withdraw consent, and who provided outcome data after randomization. | Posted | | Count of Participants | | Participants | | between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth | | | | ID | Title | Description |
|---|
| OG000 | Randomized Trial: Initial Laparotomy | Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures. | | OG001 | Randomized Trial: Initial Peritoneal Drain | Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation. |
| |
| Secondary | 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). | Analysis included all eligible participants who were consented, randomized, did not withdraw consent, and who provided outcome data after randomization. | Posted | | Count of Participants | | Participants | | between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth | | | | ID | Title | Description |
|---|
| OG000 | Randomized Trial: Initial Laparotomy | Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures. | | OG001 | Randomized Trial: Initial Peritoneal Drain | Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation. |
| |
| Secondary | 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). | Analysis included all eligible participants who were consented, randomized, did not withdraw consent, and who provided outcome data after randomization. | Posted | | Mean | Standard Deviation | days | | between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth | | | | ID | Title | Description |
|---|
| OG000 | Randomized Trial: Initial Laparotomy | Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures. | | OG001 | Randomized Trial: Initial Peritoneal Drain | Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation. |
| |
| Secondary | 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). | Analysis included all eligible participants who were consented, randomized, did not withdraw consent, and who provided outcome data after randomization. | Posted | | Mean | Standard Deviation | days | | between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth | | | | ID | Title | Description |
|---|
| OG000 | Randomized Trial: Initial Laparotomy | Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures. | | OG001 | Randomized Trial: Initial Peritoneal Drain | Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation. |
| |
| Secondary | 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). | Analysis included all eligible participants who were consented, randomized, did not withdraw consent, and who provided outcome data after randomization. | Posted | | Mean | Standard Deviation | cm | | between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth | | | | ID | Title | Description |
|---|
| OG000 | Randomized Trial: Initial Laparotomy | Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures. | | OG001 | Randomized Trial: Initial Peritoneal Drain | Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation. |
| |
| Secondary | 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). | Analysis included all eligible participants who were consented, randomized, did not withdraw consent, and who provided outcome data after randomization. | Posted | | Mean | Standard Deviation | days | | between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth | | | | ID | Title | Description |
|---|
| OG000 | Randomized Trial: Initial Laparotomy | Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures. | | OG001 | Randomized Trial: Initial Peritoneal Drain | Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation. |
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| Secondary | 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). | Analysis included all eligible participants who were consented, randomized, did not withdraw consent, and who provided outcome data after randomization. | Posted | | Mean | Standard Deviation | days | | from randomization up to 1 year following birth | | | | ID | Title | Description |
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| OG000 | Randomized Trial: Initial Laparotomy | Under general anesthesia in the NICU or operating room, a laparotomy will be performed following standard procedures. | | OG001 | Randomized Trial: Initial Peritoneal Drain | Place a one-fourth inch Penrose drain in the lower abdomen with local anesthesia and sedation. |
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