Early Predictors of Necrotizing Enterocolitis in Neonates

Recruiting

• Conditions: Necrotizing Enterocolitis

• Registration Number: NCT03210831
• Lead Sponsor: Nationwide Children's Hospital

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.

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.

Study Timeline

• Study First Submitted: 2017-07-05
• Study First Submitted QC: 2017-07-05
• Study First Posted: 2017-07-07
• Study Start: 2017-09-06
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-13
• Last Update Posted: 2024-04-16
• Primary Completion: 2026-06
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 450

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
splanchnic tissue oxygenation in population at high risk for NEC	2026	splanchnic tissue oxygenation as a predictor of NEC

Trial Locations

Locations (1)

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States