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New study aims to predict deadly gut infection in preemies before symptoms appear

NCT ID NCT03210831

Knowledge-focused Sponsor: Nationwide Children's Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks for early signs of necrotizing enterocolitis (NEC), a severe gut infection in premature babies. Researchers will use non-invasive measures and blood markers to identify at-risk infants before symptoms start. The goal is to eventually prevent the disease from progressing. The study involves 450 babies born at 30 weeks or earlier or weighing 1500 grams or less.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to a way to identify at-risk babies before they get sick, allowing early treatment to prevent severe disease.
What could go wrong
This is an observational study, not a treatment trial. It may not find reliable predictors, and results may not apply to all premature infants.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 450 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2017

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

low birth weight, preterm infants

Ages

Up to 7 days

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

necrotizing enterocolitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Necrotizing enterocolitis

Contacts and locations

Locations

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.