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New study aims to predict deadly gut disease in preterm infants

NCT ID NCT07545993

Knowledge-focused Sponsor: Guangzhou Women and Children's Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study aims to create an early warning system for necrotizing enterocolitis (NEC), a severe gut emergency in preterm infants. Researchers will analyze genetic and immune markers from 1,050 babies born before 32 weeks to identify those at highest risk. The goal is to improve early detection and prevention, potentially saving lives and reducing long-term complications.

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 create a tool to predict which preterm babies are at high risk for NEC, allowing earlier intervention and better outcomes.
What could go wrong
This is an observational study, not a treatment trial. It may not lead to immediate clinical changes, and the model needs validation across multiple centers.

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 1,050 people

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

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

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

Preterm infants born \<32 weeks

Ages

0 days to 3 months

Sex

Anyone

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: * Preterm infants with gestational age \<32 weeks * Admission to the neonatology department of the lead institution or participating institutions * Parental consent to participate in the study and approval for genetic testing using residual samples from routine blood draws. * Possession of complete perinatal and hospitalization records. Exclusion Criteria: * Congenital malformations, well-defined clinical syndromes, or chromosomal abnormalities * Death within 7 days after birth or voluntary discharge * Patients with confirmed positive diagnosis of pathogenic genes and interpretable major clinical phenotypes * Only one case of identical multiple births was retained for analysis to avoid genetic background overlap

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Conditions

The condition(s) this trial relates to.

necrotizing enterocolitis Premature Birth

As listed by the trial registrant

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

Nec - necrotizing enterocolitis

How to take part

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

  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

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  2. 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.

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