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NCT Number: NCT07531706

Cortical Tracking of Speech in the First Year of Life

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.

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Key information

Age range

30 week–34 week

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Eugenio Medea Associazione La nostra famiglia

Bosisio Parini, Lecco, 23842, Italy

Location status: Recruiting

Location contact

Chiara Cantiani

CONTACT

[email protected]

031-877924

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Electrophysiological recording

Other

Investigation of early neural markers using electrophysiology at 8 months

Behavioral Assessment

Behavioral

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

Primary outcomes

  1. Communicative Development

    Time frame: Age 18 months

    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.

Secondary outcomes

  1. Global Development

    Time frame: Age 18 months

    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.

Sponsors and collaborators

Lead sponsor

IRCCS Eugenio Medea

Other

Collaborators

  • Basque Center on Cognition, Brain and Language (BCBL)

Registry information

Official study title

Cortical Tracking of Speech in the First Year of Life: a Window Into (a)Typical Language Acquisition

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Apr 15, 2026
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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