Clinical trial Recruiting at 1 site Observational Ages 6 Months to 8

Identifying early signs of language impairments in infants

Official title: Early Neurophysiological Markers of Language Impairments: a Longitudinal Study on Infants At Familial Risk

Run by IRCCS Eugenio Medea · NCT05767242 · Data updated 2026-11-12

This study is trying to find early signs that could show if babies might have language problems later on, so we can better understand their development and help them with reading and spelling skills as they grow.

More Developmental Language Disorder trials

Quick facts

Study typeObservational
Ages6 Months to 8 Years
SexAll
Enrollment100 (estimated)
SponsorIRCCS Eugenio Medea
Academic / other
Locations1 site (Bosisio Parini, LC)
StatusRecruiting
StartedFebruary 21, 2022
Main results expectedDecember 31, 2026
Study endsDecember 31, 2026
Registry record updatedFebruary 5, 2025
Trial IDNCT05767242 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are healthy infants under 24 months, including those with a familial risk for language impairments.

Probably not a fit

Patients who may not benefit from this study include those with gestational age under 37 weeks, low birth weight, or diagnosed intellectual and neurological disorders.

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

What this trial studies

This project aims to identify early electrophysiological markers that indicate the risk of language impairments in infants. By following a cohort of infants from the Medea BabyLab until they reach school age, the study seeks to characterize their developmental trajectories and create a prognostic model that incorporates neurophysiological processes as potential biomarkers for predicting future reading and spelling skills. The study involves electrophysiological recordings and behavioral assessments to gather comprehensive data on these infants.

Why it matters

Potential benefit: If successful, this study could lead to early identification and intervention strategies for children at risk of language impairments, improving their educational outcomes.

How similar studies have gone: While the approach of identifying early neurophysiological markers is promising, it is relatively novel and has not been extensively tested in similar studies.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Healthy infants aged \<24 months
* Infants with and without familial risk for language impairments (infants are assigned to the group with familial risk if at least one first-degree relative had a certified (clinical) diagnosis of language impairment or learning disability
* 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 relative

Where it's running

  • Associazione La Nostra Famiglia - IRCCS Eugenio Medea
    Bosisio Parini, Lc, Italy
    Recruiting

Study contacts

Similar studies

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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.