Identifying early signs of Necrotizing Enterocolitis in premature infants
Clinical Model for Early Predictors of Necrotizing Enterocolitis in Neonates
This study is trying to find early signs of a serious gut condition in premature babies using simple tests to help doctors act quickly before symptoms show up.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 450 (estimated) |
| Ages | N/A to 7 Days |
| Sex | All |
| Sponsor | Nationwide Children's Hospital Academic / other |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT03210831 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify neonates at risk for Necrotizing Enterocolitis (NEC) by utilizing non-invasive measures and biochemical markers. The research will focus on premature, low birth weight infants in Neonatal Intensive Care Units (NICUs), enrolling up to 450 neonates to compare their splanchnic tissue oxygenation and gut inflammatory biomarkers against healthy controls. The goal is to detect early indicators of NEC before symptoms arise, allowing for timely interventions to prevent disease progression.
Who should consider this trial
Good fit: Ideal candidates for this study are infants born at or before 30 weeks gestational age or with a birth weight of 1500 grams or less.
Not a fit: Patients who may not benefit from this study include those born after 30 weeks gestational age or with known abdominal wall defects or complex cardiac abnormalities.
Why it matters
Potential benefit: If successful, this study could lead to earlier detection and prevention of NEC in vulnerable neonates, improving their health outcomes.
How similar studies have performed: Other studies have explored early predictors of NEC, but this specific approach using non-invasive measures and biomarkers is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Columbus, Ohio
- Nationwide Children's Hospital — Columbus, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Oluyinka Olutoye, MD, PhD — Nationwide Children's Hospital
- Study coordinator: Theresa Pennington
- Email: Theresa.Pennington@nationwidechildrens.org
- Phone: 614-355-6736
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.