Early Neurophysiological Markers of Language Impairments

IRCCS Eugenio Medea

Status: Enrolling

Conditions: Learning Disabilities; Development, Language; Developmental Language Disorder; Development, Infant

Treatments: Behavioral: Behavioral assessment; Other: Electrophysiological recording

Study type: Observational

Funder types: Other

Identifiers

NCT05767242

918

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 6 months to 8 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

100 participants in 1 patient group

MEDEA BabyLab Cohort

Treatment:

Other: Electrophysiological recording

Behavioral: Behavioral assessment