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NCT Number: NCT03210831

Early Predictors of Necrotizing Enterocolitis in Neonates

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Necrotizing Enterocolitis Digestive System Diseases Enterocolitis Enterocolitis, Necrotizing Gastroenteritis Gastrointestinal Diseases Intestinal Diseases

Age range

Up to 7 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

Primary outcomes

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

    Time frame: 2026

    splanchnic tissue oxygenation as a predictor of NEC

Sponsors and collaborators

Lead sponsor

Nationwide Children's Hospital

Other

Registry information

Official study title

Clinical Model for Early Predictors of Necrotizing Enterocolitis in Neonates

Important dates

Study start
2017
Primary completion
2026
Study completion
2026
First posted
Jul 7, 2017
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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