Effects of moderate preterm birth on language development
Official title: A Longitudinal Study of the Impact of Moderate Preterm Birth on Cortical and Subcortical Processing of Speech Sounds and Vocabulary Acquisition
Run by Assistance Publique Hopitaux De Marseille · NCT05397197 · Data updated 2026-11-12
This study is testing how being born a bit early affects language skills in babies, to help identify those who might need extra support as they grow.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 0 Days to 2 Years |
| Sex | All |
| Enrollment | 160 (estimated) |
| Sponsor | Assistance Publique Hopitaux De Marseille Academic / other |
| Locations | 1 site (Marseille) |
| Status | Recruiting |
| Started | October 19, 2022 |
| Main results expected | October 19, 2028 |
| Study ends | October 19, 2030 |
| Registry record updated | January 8, 2026 |
| Trial ID | NCT05397197 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include infants born between 32 and 36 weeks of gestation who have normal clinical examinations and reside in Marseille.
✕Probably not a fit
Patients with significant neonatal complications or conditions affecting brain development may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates how moderate preterm birth affects vocabulary acquisition in children. It focuses on infants born between 32 and 36 weeks of gestation and aims to identify neuroplasticity mechanisms related to early speech encoding through electroencephalography (EEG). The research seeks to establish predictive markers for language development, enabling early intervention for at-risk children. By understanding the cortical responses to speech sounds, the study aims to improve care for infants with potential language delays.
Why it matters
Potential benefit: If successful, this study could lead to early interventions that significantly improve language outcomes for children born prematurely.
How similar studies have gone: While there is ongoing research in this area, the specific focus on moderate preterm birth and its impact on vocabulary acquisition through EEG is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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,
Where it's running
-
Service de Neuropédiatrie
Marseille, France Recruiting
Study contacts
- Study coordinator: Beatrice Desnous, MD
- Email: beatrice.desnous@ap-hm.fr
- Phone: 04 91 38 73 67
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.