Early Predictors of Necrotizing Enterocolitis in Neonates
Clinical Model for Early Predictors of Necrotizing Enterocolitis in Neonates
1 other identifier
observational
450
1 country
1
Brief Summary
The goal of this project is to identify neonates who are predisposed to Necrotizing Enterocolitis (NEC). the investigators will determine the effectiveness of non-invasive measures as well as biochemical markers to identify neonates early in the disease process. Thus, the investigators aim to identify infants with NEC prior to the onset of symptoms to institute or test treatments in the long term to prevent the progression of the disease in these infants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2017
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 5, 2017
CompletedFirst Posted
Study publicly available on registry
July 7, 2017
CompletedStudy Start
First participant enrolled
September 6, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
June 29, 2025
May 1, 2025
8.7 years
July 5, 2017
June 27, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
splanchnic tissue oxygenation in population at high risk for NEC
splanchnic tissue oxygenation as a predictor of NEC
2026
Eligibility Criteria
low birth weight, preterm infants
You may qualify if:
- Infants born at ≤30 weeks gestational age and/or
- Infants with a birth weight ≤1500 grams
You may not qualify if:
- gestational age at birth greater than 30 weeks
- obvious dysmorphic syndromes
- any abdominal wall defect including omphalocele or gastroschisis
- any known intestinal atresia
- complex cardiac abnormalities
- any known lethal chromosomal abnormalities
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Biospecimen
Blood, urine and stools samples are collected.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Oluyinka Olutoye, MD, PhD
Nationwide Children's Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 5, 2017
First Posted
July 7, 2017
Study Start
September 6, 2017
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
June 29, 2025
Record last verified: 2025-05