Status:
RECRUITING
Prospective Study of the Feasibility of Brain Connectivity Imaging by Functional Ultrasound Imaging (fUS) in Newborn Infant
Lead Sponsor:
Institut National de la Santé Et de la Recherche Médicale, France
Conditions:
Neonates and Preterm Infants
Neonates or Premature Babies
Eligibility:
All Genders
Up to 5 years
Phase:
NA
Brief Summary
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 Europ...
Detailed Description
Introduction Neurodevelopmental disorders (NDD) result from an alteration in brain development and represent a major public health problem, affecting 1 million newborns in Europe each year. Neurodeve...
Eligibility Criteria
Inclusion
- 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
- Person subject to a judicial safeguard measure (guardianship, curatorship or safeguard of justice)
- Known malformative pathology;
- Known chromosomal abnormality;
- Known allergy to silicone
Key Trial Info
Start Date :
November 28 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2030
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT06940713
Start Date
November 28 2025
End Date
April 1 2030
Last Update
December 18 2025
Active Locations (1)
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1
Hôpital Robert Debré
Paris, France, 75019