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Impact of Moderate Preterm Birth on Vocabulary Acquisition

A Longitudinal Study of the Impact of Moderate Preterm Birth on Cortical and Subcortical Processing of Speech Sounds and Vocabulary Acquisition

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05397197
Acronym
BABYLANG
Enrollment
160
Registered
2022-05-31
Start date
2022-10-19
Completion date
2030-10-19
Last updated
2026-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature Birth

Keywords

speech acquisition, prematurity, sounds processing, EEG

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.

Interventions

OTHERElectroencephalography

experimental task, neuropsychological evaluation, clinical exam

Sponsors

Assistance Publique Hopitaux De Marseille
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
0 Days to 2 Years
Healthy volunteers
Yes

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,

Design outcomes

Primary

MeasureTime frameDescription
Study the impact of moderate prematurity on speech encoding characteristics development40 amenorrhea weeksLatency and amplitude of cortical and subcortical auditory evoked potentials in response to syllables, measured by Electroencephalography

Countries

France

Contacts

Primary ContactBeatrice Desnous, MD
beatrice.desnous@ap-hm.fr04 91 38 73 67

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026