Early Neurophysiological Markers of Language Impairments

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-21

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Development, Infant Development, Language Developmental Language Disorder Learning Disabilities

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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MEDEA BabyLab Cohort

Electrophysiological recording

Intervention Type OTHER

Investigation of early neural markers using electrophysiology at 6-12-24 months

Behavioral assessment

Intervention Type BEHAVIORAL

Individual behavioral assessment at later ages (3, 4.5, 6, and 8 years)

Interventions

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Electrophysiological recording

Investigation of early neural markers using electrophysiology at 6-12-24 months

Intervention Type OTHER

Behavioral assessment

Individual behavioral assessment at later ages (3, 4.5, 6, and 8 years)

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

6 Months

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes