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Scientists dive into amniotic fluid to unlock preterm gut mysteries

NCT ID NCT07152106

Knowledge-focused Sponsor: Maxima Medical Center 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study collects amniotic fluid from 275 pregnant women delivering at various stages, including extremely preterm. Researchers will analyze the fluid's microbes and chemicals, and link them to the baby's gut bacteria and health outcomes like necrotizing enterocolitis (NEC) and sepsis. The goal is to better understand how amniotic fluid influences gut development and infection risk in preterm infants.

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 help identify high-risk preterm infants earlier and guide future treatments to prevent serious gut infections.
What could go wrong
This is an observational study, not a treatment trial. It will not directly improve health outcomes and may not lead to any new therapies.

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 275 people

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

Started

Oct 2024

Expected to finish

Oct 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.

Who is studied

Infants included in the study group must be born between 24+0/7 and 27+6/7 weeks. AF samples are also collected from a reference group, including early midtrimester (GA ≤23+6/7 weeks), very and moderate to late preterm (GA 28+0/7-36+6/7 weeks), and full-term pregnancies (GA 37+0/7-41+6/7 weeks).

Ages

16 years and older

Sex

Female participants only

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: * Maternal age ≥16 years * Written informed consent * Successful collection of amniotic fluid Exclusion Criteria: * Pregnancies complicated by fetal congenital and/or chromosomal abnormalities. * Insufficient proficiency of Dutch or English language

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Conditions

The condition(s) this trial relates to.

chorioamnionitis fetal growth restriction necrotizing enterocolitis neonatal sepsis perinatal necrotizing enterocolitis

As listed by the trial registrant

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

Chorioamnionitis Chorioamnionitis affecting fetus or newborn Fetal growth restriction (FGR) Necrotizing enterocolitis of newborn Neonatal sepsis, early-onset Neonatal sepsis, late-onset Prematurity complications Preterm birth complication

How to take part

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

  1. The places running it

    2 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

  • Amsterdam UMC

    RECRUITING

    Amsterdam, Netherlands

  • Máxima Medical Center

    RECRUITING

    Veldhoven, Netherlands

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