New ultrasound technique could spot brain disorders in babies before symptoms appear
NCT ID NCT06940713
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
The CONEXUS study is testing a new type of brain imaging called functional ultrasound (fUS) in 76 newborns at high risk for neurodevelopmental disorders. The technique uses sound waves to measure blood flow changes in the brain, similar to a regular ultrasound but more advanced. Researchers want to see if this painless, bedside scan can detect early signs of conditions like autism or cerebral palsy, potentially allowing doctors to start treatment sooner.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- functional ultrasound imaging (fUS) device
- What this could lead to
- If successful, this could provide a new, non-invasive way to detect early signs of neurodevelopmental disorders in newborns, enabling earlier treatment.
- What could go wrong
- This is an early feasibility study with only 76 participants, so results may not apply broadly. The technique may not reliably predict disorders, and technical challenges like motion artifacts could limit success.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
About 76 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Nov 2025
- Expected to finish
-
Apr 2030
An estimate. End dates often move.
- Lead sponsor
-
A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
Up to 5 months
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Neonatal anoxic-ischemic encephalopathy are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Hôpital Robert Debré
RECRUITINGParis, 75019, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.