Status:
ENROLLING_BY_INVITATION
Efficacy of an Early Rhythmic Intervention in Infancy
Lead Sponsor:
IRCCS Eugenio Medea
Conditions:
Language Development
Language Development Disorders
Eligibility:
All Genders
6-9 years
Phase:
NA
Brief Summary
The present project develops from a wide research line aiming at identifying very early electrophysiological risk markers for neurodevelopmental disorders. Long-term goals of the study include the cha...
Eligibility Criteria
Inclusion
- Healthy infants aged between 6 and 9 months
- Infants with and without familial risk for language disorders (Infants are assigned to the group with familial risk for language disorders if at least one first-degree relative had a certified (clinical) diagnosis of language and/or learning disorders.
- Both parents are native-Italian speakers
Exclusion
- 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 relatives.
Key Trial Info
Start Date :
February 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT04755309
Start Date
February 1 2021
End Date
December 31 2026
Last Update
February 5 2025
Active Locations (1)
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1
IRCCS Eugenio Medea
Bosisio Parini, LC, Italy, 23842