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New treatment option for Neonates and Preterm Infants
Official title Prospective Study of the Feasibility of Brain Connectivity Imaging by Functional Ultrasound Imaging (fUS) in Newborn Infant
ClinicalTrials.gov ID: NCT06940713
What this study is testing
- What it's testing
- 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.
- Time commitment: about 5 years
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 5. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- 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...
- Siblings with at least one child with signs of autism spectrum disorder
You likely can't join if
- Person subject to a judicial safeguard measure (guardianship, curatorship or safeguard of justice)
- Known malformative pathology;
- Known chromosomal abnormality;
- Known allergy to silicone
See the full eligibility 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...
- 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\ 10p; Cranial Perimeter \>10p 6\. Consent of the holders of parental authority 7. Child affiliated to or in receipt of a social security scheme
- Person subject to a judicial safeguard measure (guardianship, curatorship or safeguard of justice)
- Known malformative pathology;
- Known chromosomal abnormality;
- Known allergy to silicone
The study team makes the final eligibility decision.
Where it's taking place
- Paris, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, up to 5 months. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Paris, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.