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NCT03210831 Clinical Trial

Early Predictors of Necrotizing Enterocolitis in Neonates

Necrotizing Enterocolitis Clinical Trial

Official title:
Clinical Model for Early Predictors of Necrotizing Enterocolitis in Neonates

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03210831
Other study ID # NCH-00000631
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 6, 2017
Est. completion date December 2026

Study information
Verified date April 2024
Source Nationwide Children's Hospital
Contact Theresa Pennington
Phone 614-355-6736
Email Theresa.Pennington@nationwidechildrens.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 450
Est. completion date December 2026
Est. primary completion date June 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 7 Days
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
United States Nationwide Children's Hospital Columbus Ohio

Sponsors (1)
Lead Sponsor Collaborator
Nationwide Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary splanchnic tissue oxygenation in population at high risk for NEC splanchnic tissue oxygenation as a predictor of NEC 2026
See also
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Completed NCT01745510 - Enteral Administration of Docosahexaenoic Acid to Prevent Necrotizing Enterocolitis in Preterm Neonates Phase 1/Phase 2
Enrolling by invitation NCT02050971 - Autologous Cord Blood Infusion for the Prevention and Treatment of Prematurity Complications In Preterm Neonates Phase 1