Early Neurophysiological Markers of Language Impairments
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Electrophysiological recording, Behavioral assessment.
- Who it may be relevant to
- Registry conditions: Development, Infant, Development, Language, Developmental Language Disorder, Learning Disabilities. Basic parameters: 6 months — 8 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Early Neurophysiological Markers of Language Impairments: a Longitudinal Study on Infants At Familial Risk
Overview
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.
Interventions
- Other Electrophysiological recording
Investigation of early neural markers using electrophysiology at 6-12-24 months - Behavioral Behavioral assessment
Individual behavioral assessment at later ages (3, 4.5, 6, and 8 years)
Primary outcome measures
- Expressive vocabulary at age 3 years [Time frame: Age 3 years]
- Phonological awareness at age 3 years [Time frame: Age 3 years]
- Syntactic comprehension at age 3 years [Time frame: Age 3 years]
- Lexical comprehension at age 3 years [Time frame: Age 3 years]
- Short-term verbal memory at age 4.5 years [Time frame: Age 4.5 years]
- Phonological awareness at age 4.5 years [Time frame: Age 4.5 years]
- Phonological awareness at age 6 years [Time frame: Age 6 years]
- Letter identification, knowledge, and writing at age 6 years [Time frame: Age 6 years]
- Reading (accuracy, speed and comprehension) at age 8 years [Time frame: Age 8 years]
- Spelling at age 8 years [Time frame: Age 8 years]
Secondary outcome measures (5)
- Lexical access at age 4.5 years [Time frame: Age 4.5 years]
- Naming and articulatory accuracy at age 3 years [Time frame: Age 3 years]
- Nonverbal cognitive score at age 4.5 years [Time frame: Age 4.5 years]
- Lexical access at age 6 years [Time frame: Age 6 years]
- Visual-motor integration at age 6 years [Time frame: Age 6 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- Associazione La Nostra Famiglia - IRCCS Eugenio Medea — Bosisio Parini
Identifiers
NCT: NCT05767242 · 918