Status:
RECRUITING
Impact of Moderate Preterm Birth on Vocabulary Acquisition
Lead Sponsor:
Assistance Publique Hopitaux De Marseille
Conditions:
Premature Birth
Eligibility:
All Genders
Up to 2 years
Phase:
NA
Brief Summary
Children born prematurely may present a neurodevelopmental disorder with a language delay diagnosed as early as 2-3 years of age. This situation is not uncommon: each year in France, approximately 35,...
Eligibility Criteria
Inclusion
- Infants born prematurely (32-36 weeks gestational age, GA) or at term (40-2 weeks gestational age, GA)
- Birth weight appropriate to gestational age determined by WHO growth charts (weight, height, head circumference)
- Normal clinical examination at inclusion.
- Written informed consent obtained from both parents (or single parent if single parent)
- Infant with at least one parent who speaks and understands fluent French
- Infant is affiliated with the social security system
- Infant whose parents reside in Marseille
Exclusion
- Neonatal distress (Apgar score \< 7)
- Hypoxic and ischemic encephalopathy
- Perinatal acidosis
- Intrauterine growth retardation
- Brain injury (such as intraventricular or periventricular hemorrhage, periventricular leukomalacia)
- Cerebral congenital malformations
- Neonatal epilepsy
- Any condition that in the opinion of the investigator would not be compatible with the conduct of this study
- Abnormal hearing test performed as part of the child's routine care at birth,
Key Trial Info
Start Date :
October 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 19 2030
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT05397197
Start Date
October 19 2022
End Date
October 19 2030
Last Update
January 8 2026
Active Locations (1)
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1
Service de Neuropédiatrie
Marseille, France, 13005