Impact of Moderate Preterm Birth on Vocabulary Acquisition (NCT05397197) | Clinical Trial Compass
RecruitingNot Applicable
Impact of Moderate Preterm Birth on Vocabulary Acquisition
France160 participantsStarted 2022-10-19
Plain-language 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.
Who can participate
Age range
0 Days – 2 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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,
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Study the impact of moderate prematurity on speech encoding characteristics development
Timeframe: 40 amenorrhea weeks
2
Study the impact of moderate prematurity on speech encoding characteristics development
Timeframe: 3 months
3
Study the impact of moderate prematurity on speech encoding characteristics development
Timeframe: 6 months
4
Study the impact of moderate prematurity on speech encoding characteristics development
Timeframe: 10 months
5
Study the impact of moderate prematurity on speech encoding characteristics development
Timeframe: 18 months
6
Study the impact of moderate prematurity on speech encoding characteristics development