Premature Birth Clinical Trial
— BABYLANGOfficial title:
A Longitudinal Study of the Impact of Moderate Preterm Birth on Cortical and Subcortical Processing of Speech Sounds and Vocabulary Acquisition
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.
Status | Recruiting |
Enrollment | 160 |
Est. completion date | October 18, 2027 |
Est. primary completion date | October 18, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 0 Days to 2 Years |
Eligibility | 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, |
Country | Name | City | State |
---|---|---|---|
France | Service de Neuropédiatrie | Marseille |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique Hopitaux De Marseille |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Study the impact of moderate prematurity on speech encoding characteristics development | Latency and amplitude of cortical and subcortical auditory evoked potentials in response to syllables, measured by Electroencephalography | 40 amenorrhea weeks | |
Primary | Study the impact of moderate prematurity on speech encoding characteristics development | Latency and amplitude of cortical and subcortical auditory evoked potentials in response to syllables, measured by Electroencephalography | 3 months | |
Primary | Study the impact of moderate prematurity on speech encoding characteristics development | Latency and amplitude of cortical and subcortical auditory evoked potentials in response to syllables, measured by Electroencephalography | 6 months | |
Primary | Study the impact of moderate prematurity on speech encoding characteristics development | Latency and amplitude of cortical and subcortical auditory evoked potentials in response to syllables, measured by Electroencephalography | 10 months | |
Primary | Study the impact of moderate prematurity on speech encoding characteristics development | Latency and amplitude of cortical and subcortical auditory evoked potentials in response to syllables , measured by Electroencephalography | 18 months | |
Primary | Study the impact of moderate prematurity on speech encoding characteristics development | Latency and amplitude of cortical and subcortical auditory evoked potentials in response to syllables , measured by Electroencephalography | 24 months |
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