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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Page 1 of 1 (1 locations)

1

Service de Neuropédiatrie

Marseille, France, 13005