Functional ultrasound (fUS) for measuring brain connectivity in newborns

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Hôpital Robert Debré
  Paris, France Recruiting

Study contacts

• Principal investigator: Valerie BIRAN, MD — Aphp
• Study coordinator: Valerie BIRAN, MD
• Email: valerie.biran@aphp.fr
• Phone: +33 1 40 03 41 91

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.