Impact of Moderate Preterm Birth on Vocabulary Acquisition
BABYLANG
A Longitudinal Study of the Impact of Moderate Preterm Birth on Cortical and Subcortical Processing of Speech Sounds and Vocabulary Acquisition
2 other identifiers
interventional
160
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 21, 2022
CompletedFirst Posted
Study publicly available on registry
May 31, 2022
CompletedStudy Start
First participant enrolled
October 19, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 19, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 19, 2030
January 8, 2026
January 1, 2026
6 years
May 21, 2022
January 7, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
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
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
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
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
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
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
Study Arms (1)
Longitudinal follow-up
OTHERFollow-up of children at 40 weeks of corrected age for all children and then regularly until 24 months
Interventions
experimental task, neuropsychological evaluation, clinical exam
Eligibility Criteria
You may qualify if:
- 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)
- 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
You may not qualify if:
- 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,
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Service de Neuropédiatrie
Marseille, 13005, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Francois Cremieux
AP-HM
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2022
First Posted
May 31, 2022
Study Start
October 19, 2022
Primary Completion (Estimated)
October 19, 2028
Study Completion (Estimated)
October 19, 2030
Last Updated
January 8, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share