Early Predictors of Necrotizing Enterocolitis in Neonates

Clinical Model for Early Predictors of Necrotizing Enterocolitis in Neonates

Sponsors

Lead Sponsor: Nationwide Children's Hospital

Source 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.

Overall Status Active, not recruiting
Start Date September 6, 2017
Completion Date June 2024
Primary Completion Date January 2024
Study Type Observational
Primary Outcome
Measure Time Frame
splanchnic tissue oxygenation in population at high risk for NEC 2022
Enrollment 450
Condition
Eligibility

Sampling Method: Probability Sample

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

Gender: All

Minimum Age: N/A

Maximum Age: 7 Days

Healthy Volunteers: Accepts Healthy Volunteers

Location
Facility: Nationwide Children's Hospital
Location Countries

United States

Verification Date

July 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Nationwide Children's Hospital

Investigator Full Name: Oluyinka Olutoye

Investigator Title: Principal Investigator

Keywords
Has Expanded Access No
Condition Browse
Patient Data Undecided
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

Source: ClinicalTrials.gov