Effects of moderate preterm birth on language development
A Longitudinal Study of the Impact of Moderate Preterm Birth on Cortical and Subcortical Processing of Speech Sounds and Vocabulary Acquisition
NA · Assistance Publique Hopitaux De Marseille · NCT05397197
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 0 Days to 2 Years |
| Sex | All |
| Sponsor | Assistance Publique Hopitaux De Marseille (other) |
| Locations | 1 site (Marseille) |
| Trial ID | NCT05397197 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include infants born between 32 and 36 weeks of gestation who have normal clinical examinations and reside in Marseille.
Not a fit: Patients with significant neonatal complications or conditions affecting brain development may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Marseille
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Premature Birth, speech acquisition, prematurity, sounds processing, EEG