An observational study in Development, Infant, Development, Language and Developmental Language Disorder, sponsored by IRCCS Eugenio Medea. Recruiting at 1 site in Italy. Open to participants aged 6 Months to 8 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-05.
Sponsored by IRCCS Eugenio Medea · Observational
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.
243 studies on the registry are indexed under Language; 76 are open to participants now.
This study's planned enrollment of 100 is below the median of 115 across 77 observational studies indexed under Language.
Browse Language studies →IRCCS Eugenio Medea is the lead sponsor of 108 studies on the registry; 51 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Healthy infants with and without familial risk for language impairments
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Other: Electrophysiological recording · Behavioral: Behavioral assessment
Investigation of early neural markers using electrophysiology at 6-12-24 months
Individual behavioral assessment at later ages (3, 4.5, 6, and 8 years)
Expressive vocabulary at age 3 years
Standardized score in the Language Development Survey (Rescorla, 1989; Rescorla et al., 2014). Minimum=5; Maximum=95 (higher scores mean a better outcome).
Time frame: Age 3 years
Phonological awareness at age 3 years
Raw score in a syllabic blending task (created ad hoc). Scores are percentages of accuracy (higher scores mean a better outcome).
Time frame: Age 3 years
Syntactic comprehension at age 3 years
Standardized scores in the syntactic comprehension subtests, taken from 'Test for language evaluation', Cianchetti e Fancello, 1997. Z-scores are calculated (higher scores mean a better outcome).
Time frame: Age 3 years
Lexical comprehension at age 3 years
Raw score in the lexical comprehension subtest, taken from 'Battery for language evaluation in children 4-12 years', Marini et al., 2015. Scores are percentages of accuracy (higher scores mean a better outcome).
Time frame: Age 3 years
Short-term verbal memory at age 4.5 years
Standardized scores in the pseudo-word repetition subtest, taken from 'Battery for language evaluation in children 4-12 years', Marini et al., 2015. Z-scores are calculated (higher scores mean a better outcome).
Time frame: Age 4.5 years
Phonological awareness at age 4.5 years
Standardized scores in the phonological awareness subtests taken from 'Evaluation of phonological awareness skills', Marotta et al., 2008. Mean=10, Standard Deviation=3 (higher scores mean a better outcome).
Time frame: Age 4.5 years
Phonological awareness at age 6 years
Composite score of the standardized scores in the phonological awareness subtests (phoneme identification, phonemic segmentation), Cornoldi et al., 2009. Z-scores are calculated (higher scores mean a better outcome).
Time frame: Age 6 years
Letter identification, knowledge, and writing at age 6 years
Raw scores in the letter identification, knowledge, and writing subtests, taken from "Preschool Screening", Savelli et al., 2013. Minimum=0, Maximum=20 (higher scores mean a better outcome).
Time frame: Age 6 years
Reading (accuracy, speed and comprehension) at age 8 years
Standardized scores in the reading subtest, taken from 'Reading and comprehension assessment', Bonifacci et al., 2014. Z-scores are calculated (higher scores mean a better outcome).
Time frame: Age 8 years
Spelling at age 8 years
Standardized scores in the spelling task (Marinelli et al., 2016). Z-scores are calculated (higher scores mean a better outcome).
Time frame: Age 8 years
Phonemic awareness at age 8 years
Raw scores in the spoonerisms subtest taken from 'Evaluation of phonological awareness skills', Marotta et al., 2008. Minimum=0, Maximum=30 (higher scores mean a better outcome).
Time frame: Age 8 years
Lexical access at age 4.5 years
Standardized score in Rapid Automatic Naming. Mean=10, Standard Deviation=3 (higher scores mean a better outcome).
Time frame: Age 4.5 years
Naming and articulatory accuracy at age 3 years
Raw scores in the test of naming and articulatory accuracy (created ad hoc). Scores are percentages of accuracy (higher scores mean a better outcome).
Time frame: Age 3 years
Nonverbal cognitive score at age 4.5 years
Standardized score in the block design subtest, taken from 'Wechsler Preschool and Primary Scale of Intelligence, 3rd edition'. Mean=10, Standard Deviation=3 (higher scores mean a better outcome).
Time frame: Age 4.5 years
Lexical access at age 6 years
Standardized score in Rapid Automatic Naming, taken from Urgesi et al., 2011. Z-scores are calculated (higher scores mean a better outcome).
Time frame: Age 6 years
Visual-motor integration at age 6 years
Standardized score in the 'Developmental Test of Visual-Motor Integration', Preda, 2000. Minimum=5; Maximum=95 (higher scores mean a better outcome).
Time frame: Age 6 years
Plan to share: No
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