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Prospective Study of the Feasibility of Brain Connectivity Imaging by Functional Ultrasound Imaging (fUS) in Newborn Infant

RecruitingNAAges any - 5 MonthsAllInstitut National de la Santé Et de la Recherche …
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In plain words

What the trial is, and whether it could suit you

Neurodevelopmental disorders (NDD) affect how the brain develops and can lead to lifelong difficulties with movement, learning, behavior, and thinking. Every year, around one million newborns in Europe are affected by these conditions. Some babies are at higher risk of NDD due to factors such as being born extremely premature, having poor growth in the womb, experiencing a lack of oxygen at birth, or having a family history of severe NDD. However, predicting which babies will develop these disorders is currently very challenging because there are no reliable early indicators (biomarkers) to detect them. The CONEXUS study is testing a new type of brain imaging technology called functional ultrasound imaging (fUS) to see if it can help assess brain function in newborns at high risk of NDD. This technique measures brain activity by detecting small changes in blood flow, similar to an ultra

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: 1\. For group G1 (Premature babies): Gestational children: 1a. Between 23 WA+5 days and 27 WA +6 days (extremely preterm) (G1) or 1b. Between 28 WA+0 days and 31 WA+6 days (very preterm) (G1) 2\. For the G2 group (AIE): * Children of gestational age\> 36 WA + 0 days * with neonatal anoxo-ischemic encephalopathy * treated with controlled therapeutic hypothermia (group G2) 3\. For the G3 Group (IUGR): Gestational age between 32 WA+0 days and 40 WA+6 days and with IUGR intrauterine growth restriction: birth weight \< 10 p and/or head circumference \< 10 percentile (G3 group); 4\. For the G4 group : * Siblings with at least one child with signs of autism spectrum disorder * less than 6 months of age at baseline (G4 group) 5\. For the G5 group (control): * Children of gestational age between 39 WA and 40 WA + 6 days * without pathology during pregnancy (no vasculoplacental pathology, no threat of premature delivery, no maternal corticosteroid therapy, no consumption of toxic substances) * at birth: Apgar greater than 6 at M10; pH\>7.20; lactate\< 6 mmol/l; eutrophic; Birth weight \>10p; Cranial Perimeter \>10p 6\. Consent of the holders of parental authority 7. Child affiliated to or in receipt of a social security scheme Exclusion Criteria: * Person subject to a judicial safeguard measure (guardianship, curatorship or safeguard of justice) * Known malformative pathology; * Known chromosomal abnormality; * Known allergy to silicone
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What it tests

  • Imaging Time
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Where

1 site
Hôpital Robert Debré
Paris, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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