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AI predicts deadly gut infection in preemies days before it strikes

NCT ID NCT06727877

Diagnosis Sponsor: University Hospital, Clermont-Ferrand Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study aims to see if an artificial intelligence tool can predict necrotizing enterocolitis (NEC) — a severe and often fatal gut infection — in premature babies by analyzing their stool samples. Researchers will collect stool from 1,000 premature babies across several hospitals and use AI to look for early warning signs in the gut bacteria. The goal is to identify high-risk babies days before symptoms appear, so doctors can take steps to prevent the disease.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 1,000 people

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

Started

Apr 2025

Expected to finish

Jun 2027

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.

Ages

Up to 1 day

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: * Child born prematurely (i.e. before 34 weeks of amenorrhea) in one of participating university hospitals and hospitalized in neonatal intensive care units of the AURA region's university hospitals * Child born outside CHU and transferred before 24h of life to the neonatal intensive care unit of one of thehospital participating in the study * Affiliated with a Social Security scheme Exclusion Criteria: * Child whose guardians are protected by law (guardianship, curatorship, safeguard of justice) * Children whose parents are under 18 years of age * Refusal of parental authority to participate

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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.

Healthy control Necrotizing enterocolitis (NEC)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CHU Grenoble

    NOT_YET_RECRUITING

    Grenoble, France

  • CHU Saint Etienne

    RECRUITING

    Saint-Etienne, France

  • CHU de Clermont-Ferrand

    RECRUITING

    Clermont-Ferrand, France

  • HFME

    NOT_YET_RECRUITING

    Lyon, France

  • Hopital Croix Rousse

    NOT_YET_RECRUITING

    Lyon, France

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