Necrotizing EnterocolitisNCT03210831
Early Predictors of Necrotizing Enterocolitis in Neonates
An observational study of Necrotizing Enterocolitis, run by Nationwide Children's Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages Up to 7 daysHealthy volunteers can take part
- Conditions the study is for
- Necrotizing Enterocolitis
- How many people
- 450 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Sep 2017to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 7 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: low birth weight, preterm infants
Who may be able to join
- Infants born at ≤30 weeks gestational age and/or
- Infants with a birth weight ≤1500 grams
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Official title: Clinical Model for Early Predictors of Necrotizing Enterocolitis in Neonates
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.
Read the 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.
- Conditions
- Necrotizing Enterocolitis
- Keywords
- NEC, tissue oxygenation, gut inflammation
- Medical subject headings
- Enterocolitis, Necrotizing
What is being measured
The primary outcome is the main question the study is designed to answer.
splanchnic tissue oxygenation in population at high risk for NEC
splanchnic tissue oxygenation as a predictor of NEC
Measured: 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2017
- Study start6 Sep 2017
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Necrotizing EnterocolitisStudies of the same condition, open and under way.
- More trials run by Nationwide Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oluyinka Olutoye, MD, PhD, Nationwide Children's Hospital
- Investigators
- Oluyinka Olutoye, MD, PhD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03210831
- Sponsor's protocol ID
- NCH-00000631
- Status last verified
- Oct 2026
- First submitted
- 5 Jul 2017
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Model for Early Predictors of Necrotizing Enterocolitis in Neonates
- ClinicalTrials.gov ID
- NCT03210831
- Acronym / sponsor ID
- NCH-00000631
- Conditions
- Necrotizing Enterocolitis
- Keywords
- NEC, tissue oxygenation, gut inflammation
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Study start
- 6 Sep 2017 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 7 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 7 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- low birth weight, preterm infants
Key inclusion criteria (2 listed)
- Infants born at ≤30 weeks gestational age and/or
- Infants with a birth weight ≤1500 grams
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
splanchnic tissue oxygenation in population at high risk for NEC
Time frame: 2026
splanchnic tissue oxygenation as a predictor of NEC
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Necrotizing Enterocolitis
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Effects of Enteral Feeding Regimens on NEC, Mortality, and Neurodevelopment in Very Preterm Infants
Very Preterm Infant, Necrotizing Enterocolitis (NEC)
RecruitingObservational study
The Correlation Between Red Cell Transfusion and Complications of Prematurity
Retinopathy of Prematurity (ROP), Bronchopulmonary Dysplasia (BPD)
RecruitingPhase 1
Gut Permeability and Microbiome in Preterm Infants
Prematurity Complications
Recruiting
WithHolding Enteral Feeds Around Blood Transfusion (International)
Necrotizing Enterocolitis
Not yet recruitingObservational study
Fecal Calprotectin in Breastfed vs Formula-Fed Preterm Infants and NEC
Necrotizing Enterocolitis, Premature
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oluyinka Olutoye, MD, PhD principal investigator
Nationwide Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Necrotizing Enterocolitis, run by Nationwide Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
splanchnic tissue oxygenation in population at high risk for NEC (time frame: 2026). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.