Impact of Moderate Preterm Birth on Vocabulary Acquisition

Last updated: January 7, 2026
Sponsor: Assistance Publique Hopitaux De Marseille
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Electroencephalography

Clinical Study ID

NCT05397197
2021-24
2021-A02615-36
  • Ages < 2
  • All Genders
  • Accepts Healthy Volunteers

Study 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 35,000 children are born between 32 and 36 weeks of amenorrhea.

In our most recent work, we have shown that moderate premature infants show an attenuated cortical response to a vowel change, suggesting a deficit in the cortical encoding of vowels. This work needs to be continued in order to better understand syllable encoding and identify the neuroplasticity mechanisms underlying early speech encoding.

The identification of markers to predict language development is essential for the screening of these children at risk of language delay. These children could thus benefit from early adapted care even before the appearance of language deficits.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Infants born prematurely (32-36 weeks gestational age, GA) or at term (40-2 weeksgestational 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 singleparent)

  • 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

Exclusion Criteria:

  • 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 withthe conduct of this study

  • Abnormal hearing test performed as part of the child's routine care at birth,

Study Design

Total Participants: 160
Treatment Group(s): 1
Primary Treatment: Electroencephalography
Phase:
Study Start date:
October 19, 2022
Estimated Completion Date:
October 19, 2030

Connect with a study center

  • Service de Neuropédiatrie

    Marseille, 13005
    France

    Site Not Available

  • Service de Neuropédiatrie

    Marseille 2995469, 13005
    France

    Active - Recruiting

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