Impact of Moderate Preterm Birth on Vocabulary Acquisition

NCT ID: NCT05397197

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-19
• Study Completion Date: 2030-10-19

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 35,000 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.

Conditions

Premature Birth

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Longitudinal follow-up

Follow-up of children at 40 weeks of corrected age for all children and then regularly until 24 months

Group Type: OTHER

Electroencephalography

Intervention Type: OTHER

experimental task, neuropsychological evaluation, clinical exam

Interventions

Electroencephalography

experimental task, neuropsychological evaluation, clinical exam

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 0 Days
• Maximum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Francois Cremieux

Role: STUDY_DIRECTOR

AP-HM

Locations

Service de Neuropédiatrie

Marseille, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Beatrice Desnous, MD

Role: CONTACT

beatrice.desnous@ap-hm.fr

04 91 38 73 67 ext. 33

Facility Contacts

Beatrice Desnous

Role: primary

beatrice.desnous@ap-hm.fr

33491386809

Other Identifiers

2021-A02615-36

Identifier Type: REGISTRY

Identifier Source: secondary_id

2021-24

Identifier Type: -

Identifier Source: org_study_id