Observational Study on Early Predictors of Necrotizing Enterocolitis in Neonates

This study aims to find early signs of Necrotizing Enterocolitis (NEC), a serious gut condition, in premature and low birth weight babies. Researchers will observe infants in the Neonatal Intensive Care Unit (NICU) to see if non-invasive measurements and certain markers in the body can predict NEC before symptoms appear. The goal is to identify babies at risk early so that future treatments can be developed to prevent the disease from getting worse. You might be eligible if your baby was born at 30 weeks gestation or less, or weighed 1500 grams or less at birth. The study is looking to enroll up to 450 infants, with a focus on comparing babies who develop NEC with healthy controls. The main thing being measured is splanchnic tissue oxygenation, which is the oxygen level in the gut.

Study design
This is an observational study, meaning researchers will watch and collect information without giving any specific treatments. It plans to enroll up to 450 premature and low birth weight infants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, splanchnic tissue oxygenation, will be measured in 2026.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03210831

Early Predictors of Necrotizing Enterocolitis in Neonates

Active, Not Recruiting
Not specifiedUp to 7Observational
Nationwide Children's Hospital
~450 participants
Updated 2026-06-08 on ClinicalTrials.gov

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
splanchnic tissue oxygenation in population at high risk for NEC
Measured over 2026
Necrotizing Enterocolitis
1 sites across 1 states
Ohio1
  • Oluyinka Olutoye, MD, PhD · PRINCIPAL_INVESTIGATOR · Nationwide Children's Hospital

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

Infants born at ≤30 weeks gestational age and/or
Infants with a birth weight ≤1500 grams

Exclusion

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
  • splanchnic tissue oxygenation in population at high risk for NEC2026

    splanchnic tissue oxygenation as a predictor of NEC