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
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.
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.
low birth weight, preterm infants
Exclusion Criteria:
splanchnic tissue oxygenation in population at high risk for NEC
splanchnic tissue oxygenation as a predictor of NEC
Time frame: 2026
Plan to share: Undecided
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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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Nationwide Children's Hospital