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New treatment option for Premature Birth
Official title Impact of Moderate Preterm Birth on Vocabulary Acquisition
ClinicalTrials.gov ID: NCT05397197
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 0 to 2. Healthy volunteers may be eligible.
You may be able to join 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)
- 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
You likely can't join 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
See the full eligibility 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
- 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,
The study team makes the final eligibility decision.
Where it's taking place
- Marseille, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0 days to 2 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Marseille, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.