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Recruiting Not applicable

Impact of Moderate Preterm Birth on Vocabulary Acquisition

NCT05397197 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2022-10-19
Last updated
2026-01-08

Condition(s) studied

Premature Birth

Investigational drug(s) / intervention(s)

Electroencephalography

Electroencephalography: experimental task, neuropsychological evaluation, clinical exam

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

Sex
ALL
Min age
0 Days
Max age
2 Years
Healthy volunteers
Accepted
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,

Primary outcome measure(s)

  • Study the impact of moderate prematurity on speech encoding characteristics development — 40 amenorrhea weeks
    Latency and amplitude of cortical and subcortical auditory evoked potentials in response to syllables, measured by Electroencephalography
  • Study the impact of moderate prematurity on speech encoding characteristics development — 3 months
    Latency and amplitude of cortical and subcortical auditory evoked potentials in response to syllables, measured by Electroencephalography
  • Study the impact of moderate prematurity on speech encoding characteristics development — 6 months
    Latency and amplitude of cortical and subcortical auditory evoked potentials in response to syllables, measured by Electroencephalography
  • Study the impact of moderate prematurity on speech encoding characteristics development — 10 months
    Latency and amplitude of cortical and subcortical auditory evoked potentials in response to syllables, measured by Electroencephalography
  • Study the impact of moderate prematurity on speech encoding characteristics development — 18 months
    Latency and amplitude of cortical and subcortical auditory evoked potentials in response to syllables , measured by Electroencephalography
  • Study the impact of moderate prematurity on speech encoding characteristics development — 24 months
    Latency and amplitude of cortical and subcortical auditory evoked potentials in response to syllables , measured by Electroencephalography

Trial sites (1)

FacilityCityRegionStatus
Service de Neuropédiatrie Marseille France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05397197 on ClinicalTrials.gov ↗ ← All trials in France