An observational study in Language Development, Language Development Disorders and Infant Development, sponsored by IRCCS Eugenio Medea. Recruiting at 1 site in Italy. Open to participants aged 30 Weeks to 34 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-15.
Sponsored by IRCCS Eugenio Medea · Observational
The goal of this observational study is to investigate early neural mechanisms underlying the processing of spoken language, specifically the phenomenon of cortical tracking, and to determine whether these mechanisms can serve as early predictors of later language development outcomes in infants, including both typical and atypical trajectories.
The main questions it aims to answer are:
Participants will:
Participants will be recruited from general population in Lombardia (Italy).
Exclusion Criteria:
Other: Electrophysiological recording · Behavioral: Behavioral Assessment
Other: Electrophysiological recording · Behavioral: Behavioral Assessment
Investigation of early neural markers using electrophysiology at 8 months
Behavioral Assessment at 8 months with Bayley-III Scales of Infant and Toddler Development.
Communicative Development
Standardized score in the McArthur-Bates's CDI: Words and Gestures (Infant form) adapted by Caselli et al. (2007). Percentile scores are employed to assess gestures, receptive, and expressive vocabulary. Higher scores signify better performance.
Time frame: Age 18 months
Global Development
Global development assessed with Bayley Scales of Infant and Toddler Development. Scaled scores by age (Mean = 10, Standard Deviation = 3) are computed. Higher scores mean better performance.
Time frame: Age 18 months
Plan to share: Yes — EEG recordings at age 8 months and behavioral assessment data will be shared with researchers at Basque Center on Cognition, Brain and Language (BCBL) for data analysis purposes. The BCBL team will be involved in the project for stimuli creation, data analysis, and data comparison.
Supporting information: Study protocol, Sap, Analytic code
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Language Development Disorders→
IRCCS Eugenio Medea