Development, InfantNCT05767242
Early Neurophysiological Markers of Language Impairments
An observational study of Development, Infant and Development, Language, run by IRCCS Eugenio Medea at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Development, Infant, Development, Language, Developmental Language Disorder
- What is being tested?
- Electrophysiological recording and Behavioral assessment
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 21 Feb 2022to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Healthy infants with and without familial risk for language impairments
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Associazione La Nostra Famiglia - IRCCS Eugenio Medea
Bosisio Parini, LC, 23842
Chiara Cantiani, PhD, +39031877924, chiara.cantiani@lanostrafamiglia.it
About this study
Official title: Early Neurophysiological Markers of Language Impairments: a Longitudinal Study on Infants At Familial Risk
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.
- Conditions
- Development, Infant, Development, Language, Developmental Language Disorder, Learning Disabilities
- Being tested
- Electrophysiological recording, Behavioral assessment
- Medical subject headings
- Language, Language Development Disorders, Learning Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrophysiological recordingOther
Investigation of early neural markers using electrophysiology at 6-12-24 months
Behavioral assessmentBehavioural
Individual behavioral assessment at later ages (3, 4.5, 6, and 8 years)
| Study group | Role | What they receive |
|---|---|---|
| MEDEA BabyLab Cohort | Not described Receives: Other: Electrophysiological recording; Behavioral: Behavioral assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Age 8 years
Secondary outcomes (5)
Lexical access at age 4.5 years
Standardized score in Rapid Automatic Naming. Mean=10, Standard Deviation=3 (higher scores mean a better outcome).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Age 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2023
- Study start21 Feb 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Development, InfantStudies of the same condition, open and under way.
- More trials run by IRCCS Eugenio MedeaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Eugenio Medea
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05767242
- Sponsor's protocol ID
- 918
- Status last verified
- Feb 2025
- First submitted
- 26 Jan 2023
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Neurophysiological Markers of Language Impairments: a Longitudinal Study on Infants At Familial Risk
- ClinicalTrials.gov ID
- NCT05767242
- Acronym / sponsor ID
- 918
- Conditions
- Development, Infant, Development, Language, Developmental Language Disorder, Learning Disabilities
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- IRCCS Eugenio MedeaUniversity, hospital or other
- Study start
- 21 Feb 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 14 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MEDEA BabyLab Cohort | – | Other: Electrophysiological recording, Behavioral: Behavioral assessment |
Who may qualify
- Ages
- 6 months to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Healthy infants with and without familial risk for language impairments
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrophysiological recordingInvestigation of early neural markers using electrophysiology at 6-12-24 months | Other | MEDEA BabyLab Cohort |
| Behavioral assessmentIndividual behavioral assessment at later ages (3, 4.5, 6, and 8 years) | Behavioural | MEDEA BabyLab Cohort |
Primary outcome
Expressive vocabulary at age 3 years
Time frame: 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).
Phonological awareness at age 3 years
Time frame: Age 3 years
Raw score in a syllabic blending task (created ad hoc). Scores are percentages of accuracy (higher scores mean a better outcome).
Syntactic comprehension at age 3 years
Time frame: 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).
Lexical comprehension at age 3 years
Time frame: 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).
Short-term verbal memory at age 4.5 years
Time frame: 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).
Phonological awareness at age 4.5 years
Time frame: 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).
Phonological awareness at age 6 years
Time frame: 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).
Letter identification, knowledge, and writing at age 6 years
Time frame: 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).
Reading (accuracy, speed and comprehension) at age 8 years
Time frame: 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).
Spelling at age 8 years
Time frame: Age 8 years
Standardized scores in the spelling task (Marinelli et al., 2016). Z-scores are calculated (higher scores mean a better outcome).
Phonemic awareness at age 8 years
Time frame: 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).
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Development, Infant
RecruitingObservational study
Impact of Vestibular Function on Deaf Infants' Activities of Daily Living
Vestibular Dysfunction, Hearing Loss
Recruiting
Tiny Tummies - A Milk Study
Gut Microbiome, Neurocognitive Correlates of Eating Habits
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingObservational study
Motor Development and Early Predictors of Psychomotor Outcomes in Preterm and Term Infants Assessed by MOS-R and Caregiver Questionnaire at 18 and 36 Months
Neurodevelopmental Disorders, Motor Skills Disorders
RecruitingObservational study
Improving Nutrition for Babies Born by Caesarean Section
Breastfeeding Mothers of Legal Age, Their Babies Under 6 Months Old Born Vaginally
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Development, Infant and Development, Language, run by IRCCS Eugenio Medea at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chiara Cantiani, PhD (+39031877924, chiara.cantiani@lanostrafamiglia.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expressive vocabulary at age 3 years (time frame: Age 3 years). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2025.