NCT05397197 Impact of Moderate Preterm Birth on Vocabulary Acquisition
| NCT ID | NCT05397197 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique Hopitaux De Marseille |
| Condition | Premature Birth |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2022-10-19 |
| Primary Completion | 2028-10-19 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 160 participants in total. It began in 2022-10-19 with a primary completion date of 2028-10-19.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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,
Contact & Investigator
Francois Cremieux
STUDY DIRECTOR
AP-HM
Frequently Asked Questions
Who can join the NCT05397197 clinical trial?
This trial is open to participants of all sexes, aged 0 Days or older, up to 2 Years, studying Premature Birth. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05397197 currently recruiting?
Yes, NCT05397197 is actively recruiting participants. Contact the research team at beatrice.desnous@ap-hm.fr for enrollment information.
Where is the NCT05397197 trial being conducted?
This trial is being conducted at Marseille, France.
Who is sponsoring the NCT05397197 clinical trial?
NCT05397197 is sponsored by Assistance Publique Hopitaux De Marseille. The principal investigator is Francois Cremieux at AP-HM. The trial plans to enroll 160 participants.