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Baby brain scans could predict language delays before toddlerhood

NCT ID NCT07531706

Knowledge-focused Sponsor: IRCCS Eugenio Medea 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 8-month-old babies' brains process speech sounds, using a non-invasive EEG cap. Researchers want to see if differences in brain activity can predict language skills at 18 months, especially in infants with a family history of language or learning disorders. The goal is to find early markers for language delays, not to test a treatment.

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 study could help identify early signs of language delays in infants, allowing for earlier support and intervention.
What could go wrong
This is an observational study, not a treatment trial. It may not find clear links between brain activity and later language skills, and results may not apply to all infants.

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 50 people

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

Started

Oct 2025

Expected to finish

Feb 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

Participants will be recruited from general population in Lombardia (Italy).

Ages

30 to 34 weeks

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: * Healthy infants aged between 7 and 8 months * Infants with and without familial risk for language disorders (Infants are assigned to the group with familial risk for language disorders if at least one first-degree relative had a certified (clinical) diagnosis of language and/or learning disorders). * Both parents are native-Italian speakers Exclusion Criteria: * Gestational age \< 37 weeks and/or birth-weight \< 2500 grams * APGAR scores at birth at 1' and 5' \< 7 * Bayley Cognitive Score \< 7 * Presence of certified diagnosis of intellectual deficiency, attention-deficit disorder, sensorial and neurological disorders or autism within first-degree relatives.

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Conditions

The condition(s) this trial relates to.

Language Development Disorders language disorder

As listed by the trial registrant

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

Infant development Infant developmental assessment Language development Language development disorders

How to take part

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

  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

  • IRCCS Eugenio Medea Associazione La nostra famiglia

    RECRUITING

    Bosisio Parini, Lecco, 23842, Italy

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