RecruitingNot ApplicableNCT06940713

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

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


Sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Enrollment

76 participants

Start Date

Nov 28, 2025

Study Type

INTERVENTIONAL

Conditions

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 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 ultrasound scan but using advanced imaging technology. Researchers believe this method, known as fC-fUS imaging, could help identify early signs of neurodevelopmental disorders. Preliminary studies have shown that fUS imaging can detect brain activity changes in newborns, such as differences between sleep states or during epileptic seizures. The CONEXUS study will expand on this by improving the imaging technology and testing it in a larger group of newborns, including those born prematurely, those with restricted growth, those who needed cooling treatment after birth due to lack of oxygen, and those at risk for autism spectrum disorder (ASD). The study is being conducted in multiple hospitals in France over five years, involving newborn intensive care, pediatrics, and child psychiatry teams. It is a feasibility study, meaning researchers aim to test whether this imaging technique is practical and effective for use in newborns. Babies will have short, painless fUS scans that focus on brain regions involved in movement, hearing, vision, and attention. Ultimately, the goal of CONEXUS is to demonstrate that fC-fUS imaging can help doctors understand early brain development and identify signs of neurodevelopmental disorders before symptoms appear. If successful, this technique could improve early diagnosis, allowing doctors to start treatment sooner and improve long-term outcomes for affected children. This research has the potential to transform neonatal care by providing a new tool for detecting and monitoring brain function in newborns.


Eligibility

Max Age: 5 Months

Inclusion Criteria17

  • \. For group G1 (Premature babies):
  • Gestational children:
  • a. Between 23 WA+5 days and 27 WA +6 days (extremely preterm) (G1) or
  • b. Between 28 WA+0 days and 31 WA+6 days (very preterm) (G1)
  • \. 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)
  • \. 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);
  • \. 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)
  • \. 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
  • \. Consent of the holders of parental authority 7. Child affiliated to or in receipt of a social security scheme

Exclusion Criteria4

  • 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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Interventions

DEVICEImaging Time

fUS: transfontanellar functional ultrasound imaging, performed using the CONEXUS system. fUS-EEG: transfontanellar functional ultrasound imaging, performed using the CONEXUS system, performed simultaneously with an EEG examination. The fUS examinations consist of recording brain activity for a few minutes in one of the imaging planes (Posterior Coronal, Median Coronal, Frontal Coronal, Right Para-sagittal, Right/Left Para-sagittal, 3-plane Antero-posterior Coronal) including structures involved in brain functional connectivity networks (somatosensory, auditory, visual, salience). These fUS examinations are conducted to perform longitudinal follow-up of patients in the 5 different groups.


Locations(1)

Hôpital Robert Debré

Paris, France

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NCT06940713


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