Impact of Moderate Preterm Birth on Vocabulary Acquisition (BABYLANG)

Public Assistance-Hospitals of Marseille (AP-HM)

Status: Enrolling

Conditions: Premature Birth

Treatments: Other: Electroencephalography

Study type: Interventional

Funder types: Other

Identifiers

NCT05397197

2021-A02615-36 (Registry Identifier)

2021-24

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: All

Ages: Under 2 years old

Volunteers: Accepts Healthy Volunteers

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,

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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160 participants in 1 patient group

Longitudinal follow-up

Other group

Description:

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

Treatment:

Other: Electroencephalography