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Preterm Babies' brains show subtle speech processing differences

NCT ID NCT05397197

Knowledge-focused Sponsor: Assistance Publique Hopitaux De Marseille Source: ClinicalTrials.gov ↗

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at how being born moderately early (32-36 weeks) affects the way babies' brains process speech sounds and learn words. Researchers will measure brain activity using EEG while babies listen to syllables, and track their vocabulary growth over time. The goal is to find early signs that could predict language delays, so these children can get help sooner. About 160 infants will take part.

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 160 people

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

Started

Oct 2022

Expected to finish

Oct 2030

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

0 days to 2 years

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 prematurely (32-36 weeks gestational age, GA) or at term (40-2 weeks gestational age, GA) * Birth weight appropriate to gestational age determined by WHO growth charts (weight, height, head circumference) * Normal clinical examination at inclusion. * Written informed consent obtained from both parents (or single parent if single parent) * Infant with at least one parent who speaks and understands fluent French * Infant is affiliated with the social security system * Infant whose parents reside in Marseille Exclusion Criteria: * Neonatal distress (Apgar score \< 7) * Hypoxic and ischemic encephalopathy * Perinatal acidosis * Intrauterine growth retardation * Brain injury (such as intraventricular or periventricular hemorrhage, periventricular leukomalacia) * Cerebral congenital malformations * Neonatal epilepsy * Any condition that in the opinion of the investigator would not be compatible with the conduct of this study * Abnormal hearing test performed as part of the child's routine care at birth,

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Conditions

The condition(s) this trial relates to.

Premature Birth

As listed by the trial registrant

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

Premature birth

How to take part

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  1. The places running it

    1 site. 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

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Contacts and locations

Locations

  • Service de Neuropédiatrie

    RECRUITING

    Marseille, 13005, France

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