CClinicalTrials.gg
RecruitingNCT07531706Updated Apr 15, 2026

Cortical Tracking of Speech in the First Year of Life

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

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
30 Weeks to 34 Weeks
Sex
All
01

Study summary

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:

  • How do infants with and without a familial history of language and learning impairments differ in their neural ability to track speech and non-speech auditory stimuli at an early stage of development (around 8 months of age)?
  • To what extent do early cortical tracking mechanisms predict later language abilities, including both receptive and expressive skills, measured at approximately 18 months of age? Researchers will compare infants with a familial risk for language and learning impairments (FH+) to infants without such risk (FH-) to determine whether differences in early neural processing of auditory stimuli are associated with later language outcomes.

Participants will:

  • undergo a neurophysiological assessment involving non-invasive electroencephalographic (EEG) recording while being exposed to auditory stimuli, including: speech stimuli (pre-recorded simple stories in Italian, presented in infant-directed speech); non-speech stimuli (musical sounds matched for rhythmic and acoustic properties)
  • take part in a developmental assessment at approximately 8 months of age, including standardized measures of cognitive and early linguistic abilities
  • be involved in a follow-up assessment approximately 10 months later (around 18 months of age), during which standardized tests will evaluate language comprehension and production abilities
  • have additional background information collected, including family history of language and learning disorders and socio-demographic characteristics, to better understand potential risk and protective factors The study follows a longitudinal design and uses non-invasive procedures that do not require active responses from the infant.
02

Conditions studied

  • Language Development
  • Language Development Disorders
  • Infant Development
  • Infant Developmental Assessment
03

Who can participate

Ages eligible
30 Weeks to 34 Weeks
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Participants will be recruited from general population in Lombardia (Italy).

Inclusion criteria

  • Healthy infants aged between 7 and 8 months
  • Infants with and without familial risk for language disorders (Infants are assigned to the group with familial risk for language disorders if at least one first-degree relative had a certified (clinical) diagnosis of language and/or learning disorders).
  • Both parents are native-Italian speakers

Exclusion criteria

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 relatives.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

Groups and cohorts

  • General population

    Other: Electrophysiological recording · Behavioral: Behavioral Assessment

  • Infants at familiar risk for language and learning impairment

    Other: Electrophysiological recording · Behavioral: Behavioral Assessment

Interventions

  • OtherElectrophysiological recording

    Investigation of early neural markers using electrophysiology at 8 months

  • BehavioralBehavioral Assessment

    Behavioral Assessment at 8 months with Bayley-III Scales of Infant and Toddler Development.

05

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

06

Study locations

1 of 1 sites recruiting
07

References and documents

Individual participant data

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

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07531706
Lead sponsor
IRCCS Eugenio Medea
Collaborators
Basque Center on Cognition, Brain and Language (BCBL)
Responsible party
Sponsor
First posted
Apr 15, 2026
Start date
Oct 14, 2025
Primary completion
Dec 2027 (estimated)
Completion
Feb 2028 (estimated)
Last update
Apr 15, 2026

Oversight

Data monitoring committee
No
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