Functional ultrasound (fUS) for measuring brain connectivity in newborns

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

This project tests whether a new bedside functional ultrasound (fUS) scan can measure brain connectivity in newborns at high risk of neurodevelopmental problems, including very preterm infants, babies with growth restriction, or those with oxygen injury at birth.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 76 (estimated)
• Ages: N/A to 5 Months
• Sex: All
• Sponsor: Institut National de la Santé Et de la Recherche Médicale, France (Government)
• Locations: 1 site (Paris)
• Trial ID: NCT06940713 on ClinicalTrials.gov

What this trial studies

The CONEXUS protocol uses an ultrafast functional ultrasound workstation (Conexus) to capture bedside images of cerebral blood‑flow changes as a proxy for brain activity and connectivity in neonates. The study enrolls several groups including extremely and very preterm infants, term infants with anoxic‑ischemic encephalopathy treated with therapeutic hypothermia, infants with intrauterine growth restriction, siblings under 6 months of age of a child with autism, and healthy term newborn controls. Imaging is noninvasive and performed in the neonatal unit using specialized software and probes to acquire fUS data and derive functional connectivity metrics. The primary goal is to test feasibility of bedside fUS acquisition and to collect preliminary biomarker data that could later be correlated with developmental outcomes.

Who should consider this trial

Good fit: Ideal candidates are newborns in the specified groups: extremely/very preterm infants, term infants with neonatal anoxic‑ischemic encephalopathy treated with hypothermia, infants with intrauterine growth restriction, siblings under 6 months of age of a child with autism, and healthy term controls.

Not a fit: Because this is a feasibility imaging protocol rather than a treatment, infants outside the targeted risk groups or those who cannot safely undergo bedside ultrasound (for example due to clinical instability or lack of an acoustic window) are unlikely to receive direct clinical benefit from participation.

Why it matters

Potential benefit: If successful, fUS could provide an early, bedside biomarker of brain function that helps identify newborns at higher risk for later neurodevelopmental disorders and guide closer monitoring or early interventions.

How similar studies have performed: Functional ultrasound is an emerging imaging method with promising preclinical and early adult/experimental human data, but clinical application for mapping brain connectivity in newborns is novel and not yet widely validated.

Eligibility criteria

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

Where this trial is running

Paris

• Hôpital Robert Debré — Paris, France (Recruiting)

Study contacts

• Principal investigator: Valerie BIRAN, MD — Aphp
• Study coordinator: Valerie BIRAN, MD

Conditions Neonates and Preterm Infants; Neonates or Premature Babies; ultrasound imaging; functional ultrasound; neonatal intensive care imaging; prematurity; preterm; anoxo-ischemic encephalopathy