NCT05767242 Early Neurophysiological Markers of Language Impairments
| NCT ID | NCT05767242 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS Eugenio Medea |
| Condition | Development, Infant |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2022-02-21 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2022-02-21 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The present project aims at identifying very early electrophysiological risk markers for language impairments. The long-term goals of the study include the characterization of learning developmental trajectories in children at high risk for language impairments. In this project, all the infants of the Medea BabyLab cohort are followed-up until school age. Since these infants have complete information on early electrophysiological markers, the final goal of the project is the characterization of their learning developmental trajectories and the construction of a multi-factor prognostic model that includes the neurophysiological processes underlying basic-level skills as potential biomarkers for predicting later reading and spelling skills.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05767242 clinical trial?
This trial is open to participants of all sexes, aged 6 Months or older, up to 8 Years, studying Development, Infant. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05767242 currently recruiting?
Yes, NCT05767242 is actively recruiting participants. Contact the research team at chiara.cantiani@lanostrafamiglia.it for enrollment information.
Where is the NCT05767242 trial being conducted?
This trial is being conducted at Bosisio Parini, Italy.
Who is sponsoring the NCT05767242 clinical trial?
NCT05767242 is sponsored by IRCCS Eugenio Medea. The trial plans to enroll 100 participants.