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 2026-10-27.
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.
228 studies on the registry are indexed under Enterocolitis, Necrotizing; 44 are open to participants now.
This study's planned enrollment of 450 is above the median of 144 across 95 observational studies indexed under Enterocolitis, Necrotizing.
Browse Enterocolitis, Necrotizing studies →Nationwide Children's Hospital is the lead sponsor of 233 studies on the registry; 43 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 9 (53%) have results posted.
Counted across the registry records on this site, refreshed daily.
low birth weight, preterm infants
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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
No publications or documents are linked to this record.
Started Sep 2017 (actual). Primary completion is estimated for Dec 2026, 111 months after the start.
Of 39 observational studies under Enterocolitis, Necrotizing, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 115. This study's planned 111 months is above that.
Primary completion moved once since we started tracking on Sep 25, 2026: Sep 2026 → Dec 2026, on Oct 27, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Nationwide Children's Hospital →