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Study aims to predict which preterm babies with growth problems face the highest health risks

NCT ID NCT07466693

Knowledge-focused Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This observational study looks at preterm babies born with early fetal growth restriction (poor growth in the womb) to understand how factors like mother's health and blood flow changes in the womb affect the baby's health after birth. Researchers will compare 200 such babies to 600 preterm babies without growth problems. The goal is to better predict risks and improve care, not to test a new treatment.

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 600 people

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

Started

Mar 2026

Expected to finish

Sep 2028

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

Mothers and their preterm neonates, including both subjects with FGR and Doppler alterations (UA bs-, UA bs+, UA+DV) and controls without evidence of FGR or flow velocity alterations.

Ages

Up to 45 years

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: * Cases: neonates with a gestational age ≤32 weeks and/or birth weight \< 1500 g, with a prenatal history positive for FGR (fetal weight \< 10th percentile and/or abdominal circumference/fetal weight ratio \< 10th percentile) and abnormal fetal and/or utero-placental Doppler findings * Controls: neonates with a gestational age ≤32 weeks and/or birth weight \< 1500 g, without prenatal evidence of FGR or Doppler flow abnormalities * Obtaining informed consent. Exclusion Criteria: * Fetal malformations and/or suspected or known genetic anomalies * Maternal substance abuse during pregnancy * Twin pregnancies.

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Conditions

The condition(s) this trial relates to.

fetal growth restriction

As listed by the trial registrant

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

Early fetal growth restriction (FGR)

Contacts and locations

Locations

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    Bologna, Bologna, 40138, Italy