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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05397197
Other study ID # 2021-24
Secondary ID 2021-A02615-36
Status Recruiting
Phase N/A
First received
Last updated
Start date October 19, 2022
Est. completion date October 18, 2027

Study information

Verified date January 2024
Source Assistance Publique Hopitaux De Marseille
Contact Beatrice Desnous, MD
Phone 04 91 38 73 67
Email beatrice.desnous@ap-hm.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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,

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Electroencephalography
experimental task, neuropsychological evaluation, clinical exam

Locations

Country Name City State
France Service de Neuropédiatrie Marseille

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

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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