Identifying early signs of language impairments in infants
Early Neurophysiological Markers of Language Impairments: a Longitudinal Study on Infants At Familial Risk
This study is trying to find early signs that could show if babies might have language problems later on, so we can better understand their development and help them with reading and spelling skills as they grow.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 6 Months to 8 Years |
| Sex | All |
| Sponsor | IRCCS Eugenio Medea Academic / other |
| Locations | 1 site (Bosisio Parini, LC) |
| Trial ID | NCT05767242 on ClinicalTrials.gov |
What this trial studies
This project aims to identify early electrophysiological markers that indicate the risk of language impairments in infants. By following a cohort of infants from the Medea BabyLab until they reach school age, the study seeks to characterize their developmental trajectories and create a prognostic model that incorporates neurophysiological processes as potential biomarkers for predicting future reading and spelling skills. The study involves electrophysiological recordings and behavioral assessments to gather comprehensive data on these infants.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy infants under 24 months, including those with a familial risk for language impairments.
Not a fit: Patients who may not benefit from this study include those with gestational age under 37 weeks, low birth weight, or diagnosed intellectual and neurological disorders.
Why it matters
Potential benefit: If successful, this study could lead to early identification and intervention strategies for children at risk of language impairments, improving their educational outcomes.
How similar studies have performed: While the approach of identifying early neurophysiological markers is promising, it is relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bosisio Parini, LC
- Associazione La Nostra Famiglia - IRCCS Eugenio Medea — Bosisio Parini, Lc, Italy (Recruiting)
Study contacts
- Study coordinator: Chiara Cantiani, PhD
- Email: chiara.cantiani@lanostrafamiglia.it
- Phone: +39031877924
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.