Clinical trial Recruiting at 1 site Observational Ages 30 Weeks to 34 Weeks

How infants' brains track speech during the first year

Official title: Cortical Tracking of Speech in the First Year of Life: a Window Into (a)Typical Language Acquisition

Run by IRCCS Eugenio Medea · NCT07531706 · Data updated 2026-11-12

This study will test whether 7–8 month-old babies' brain responses to speech predict their receptive and expressive language skills at about 18 months, comparing infants with and without a family history of language or learning problems.

Quick facts

Study typeObservational
Ages30 Weeks to 34 Weeks
SexAll
Enrollment50 (estimated)
SponsorIRCCS Eugenio Medea
Academic / other
Locations1 site (Bosisio Parini, Lecco)
StatusRecruiting
StartedOctober 14, 2025
Main results expectedDecember 2027
Study endsFebruary 2028
Registry record updatedApril 15, 2026
Trial IDNCT07531706 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Healthy infants aged 7–8 months whose both parents are native Italian speakers, including those with and without a first-degree family history of diagnosed language or learning disorders.

Probably not a fit

Infants born before 37 weeks, with birth weight under 2500 g, low APGAR scores, low Bayley cognitive scores, major sensorineural or neurological conditions, or with excluded family histories are not eligible and would not benefit from this protocol.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study records electrophysiological responses while healthy infants listen to speech and matched non-speech sounds at around 7–8 months, and also collects behavioral measures at the same visit. Infants are grouped by familial risk (at least one first-degree relative with a clinical diagnosis of language or learning disorder) versus no familial risk. Language outcomes, including receptive and expressive skills, are measured at approximately 18 months to test whether early neural cortical tracking predicts later development. The approach aims to identify early neural markers that could distinguish typical from atypical language trajectories.

Why it matters

Potential benefit: If cortical tracking reliably predicts later language outcomes, clinicians could identify at-risk infants earlier and offer targeted early support or monitoring.

How similar studies have gone: Previous EEG work measuring cortical tracking in infants and young children has shown promising links to later language skills, but predictable clinical application remains limited and is still being established.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • IRCCS Eugenio Medea Associazione La nostra famiglia
    Bosisio Parini, Lecco, Italy
    Recruiting

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.