Clinical trial NCT05767242: Early Neurophysiological Markers of Language Impairments
Official title: Early Neurophysiological Markers of Language Impairments: a Longitudinal Study on Infants At Familial Risk
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Development, Infant
Development, Language
Developmental Language Disorder
Learning Disabilities
Lead sponsor: IRCCS Eugenio Medea
Sponsor class: OTHER
First posted: 2023-03-14
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy infants with and without familial risk for language impairments

Brief summary: 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.


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

Primary outcomes:
measure: Expressive vocabulary at age 3 years
timeFrame: Age 3 years
measure: Phonological awareness at age 3 years
timeFrame: Age 3 years
measure: Syntactic comprehension at age 3 years
timeFrame: Age 3 years
measure: Lexical comprehension at age 3 years
timeFrame: Age 3 years
measure: Short-term verbal memory at age 4.5 years
timeFrame: Age 4.5 years
measure: Phonological awareness at age 4.5 years
timeFrame: Age 4.5 years
measure: Phonological awareness at age 6 years
timeFrame: Age 6 years
measure: Letter identification, knowledge, and writing at age 6 years
timeFrame: Age 6 years
measure: Reading (accuracy, speed and comprehension) at age 8 years
timeFrame: Age 8 years
measure: Spelling at age 8 years
timeFrame: Age 8 years
measure: Phonemic awareness at age 8 years
timeFrame: Age 8 years
Secondary outcomes:
measure: Lexical access at age 4.5 years
timeFrame: Age 4.5 years
measure: Naming and articulatory accuracy at age 3 years
timeFrame: Age 3 years
measure: Nonverbal cognitive score at age 4.5 years
timeFrame: Age 4.5 years
measure: Lexical access at age 6 years
timeFrame: Age 6 years
measure: Visual-motor integration at age 6 years
timeFrame: Age 6 years
Other outcomes:
Locations:
city: Bosisio Parini
country: Italy
facility: Associazione La Nostra Famiglia - IRCCS Eugenio Medea
state: LC
Study officials:
References: