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Active, not recruitingNCT03210831Updated Jun 8, 2026

Early Predictors of Necrotizing Enterocolitis in Neonates

An observational study in Necrotizing Enterocolitis, sponsored by Nationwide Children's Hospital. Active, not recruiting at 1 site in United States. Open to participants aged Up to 7 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-08.

Sponsored by Nationwide Children's Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
450
Ages
Up to 7 Days
Sex
All
01

Study 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.

Read the detailed description

The study will enroll premature, low birth weight infants in the Neonatal Intensive Care Units (NICU). Potential study subjects will be identified upon delivery, or transfer to the NICU, and notification by the neonatology service. Infants born at less than 30 weeks gestational age, birth weight less than or equal to 1500 grams will be eligible for enrollment in the study. The purpose of the study designed is to compare the splanchnic tissue oxygenation index and gut inflammatory biomarkers of patients with any stage of NEC with healthy controls. Since we will not be able to determine which patients will develop NEC a priori, we will anticipate enrolling up to 450 neonates to identify 15 neonates with NEC.

02

Conditions studied

  • Necrotizing Enterocolitis

Keywords

  • NEC, tissue oxygenation, gut inflammation
03

Who can participate

Ages eligible
Up to 7 Days
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

low birth weight, preterm infants

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
450 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna
05

What researchers measure

Primary outcomes

  1. splanchnic tissue oxygenation in population at high risk for NEC

    splanchnic tissue oxygenation as a predictor of NEC

    Time frame: 2026

06

Study locations

1 site
  • Nationwide Children's Hospital
    Columbus, Ohio 43205, United States
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03210831
Lead sponsor
Nationwide Children's Hospital
Responsible party
Oluyinka Olutoye, MD, PhD (Principal Investigator, Nationwide Children's Hospital) — Principal investigator
First posted
Jul 7, 2017
Start date
Sep 6, 2017
Primary completion
Sep 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Jun 8, 2026

Study contacts

Oluyinka Olutoye, MD, PhD
principal investigator · Nationwide Children's Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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