Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Death or Neurodevelopmental Impairment (NDI) |
Death or NDI at 18-22 months corrected age |
at 18-22 months corrected age |
|
Secondary |
Death |
Death by 18-22 months corrected age |
by 18-22 months corrected age |
|
Secondary |
Survival With Neurodevelopmental Impairment (NDI) |
NDI at 18-22 months corrected age (among survivors) |
by 18-22 months corrected age |
|
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 |
up to the follow-up visit completed within the 18-22 months corrected age window |
|
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. |
up to the follow-up visit completed within the 18-22 months corrected age window |
|
Secondary |
Death or Blindness |
Death within 18-22 months corrected age or blindness at 18-22 months corrected age |
up to the follow-up visit completed within the 18-22 months corrected age window |
|
Secondary |
Death or Hearing Loss |
Death within 18-22 months corrected age or hearing loss at 18-22 months corrected age |
up to the follow-up visit completed within the 18-22 months corrected age window |
|
Secondary |
Subsequent Laparotomy |
Subsequent laparotomy after initial surgery |
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 |
|
Secondary |
Any Intraoperative Complications During Any Surgery |
Any intraoperative complications during any surgery |
between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth |
|
Secondary |
Any Wound Dehiscence |
Any wound dehiscence during any surgery |
between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth |
|
Secondary |
Any Intra-abdominal Abscess |
Any intra-abdominal abscess during any surgery |
between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth |
|
Secondary |
Any Intestinal Stricture |
Any intestinal stricture during any surgery |
between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth |
|
Secondary |
Any Late Onset Sepsis |
Any late onset sepsis after randomization |
between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth |
|
Secondary |
Any Parenteral Nutrition (PN)-Associated Cholestasis |
Any Parenteral nutrition (PN)-associated cholestasis during any surgery |
between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth |
|
Secondary |
Any Severe IVH |
Any severe IVH ater randomization |
between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth |
|
Secondary |
Duration of Mechanical Ventilation |
Duration of mechanical ventilation while on study |
between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth |
|
Secondary |
Duration of Parenteral Nutrition |
Duration of parenteral nutrition while on study |
between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth |
|
Secondary |
Final Bowel Length |
Final bowel length after last surgery |
between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth |
|
Secondary |
Time to Full Feeds |
Time to full feeds while on study |
between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth |
|
Secondary |
Length of Hospital Stay |
Length of hospital stay while on study |
from randomization up to 1 year following birth |
|
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). |
at 18-22 months corrected age |
|
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). |
by 18-22 months corrected age |
|
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). |
by 18-22 months corrected age |
|
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). |
up to the follow-up visit completed within the 18-22 months corrected age window |
|
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. |
up to the follow-up visit completed within the 18-22 months corrected age window |
|
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). |
up to the follow-up visit completed within the 18-22 months corrected age window |
|
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). |
up to the follow-up visit completed within the 18-22 months corrected age window |
|
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). |
between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth |
|
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). |
between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth |
|
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). |
between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth |
|
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). |
between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth |
|
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). |
between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth |
|
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). |
between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth |
|
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). |
between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth |
|
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). |
between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth |
|
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). |
between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth |
|
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). |
between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth |
|
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). |
between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth |
|
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). |
between randomization and Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth |
|
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). |
from randomization up to 1 year following birth |
|