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Brain Ultrafast Ultrasound Imaging

Brain Ultrafast Ultrasound Imaging: Application in Pediatric Cardiology: Brain Ultrafast

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07299721
Acronym
Brain Ultrafas
Enrollment
300
Registered
2025-12-23
Start date
2026-01-01
Completion date
2029-01-01
Last updated
2025-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CHD - Congenital Heart Disease

Keywords

Congenital Heart Disease, Paediatric, Cardiac Imaging, Ultrafast ultrasounf

Brief summary

Congenital heart defects affect 1 in 100 births in France, with rising prevalence due to better care. Despite improved survival, 40% of children post-surgery face neurological impairments, and some of them show brain lesions. Causes include heart defects, genetic syndromes, and surgeries. Some heart defects and support systems increase cerebral risks. Monitoring cerebral perfusion is difficult to assess but emerging ultrafast ultrasound offers real-time, non-invasive blood flow insights.

Detailed description

Congenital heart defects affect 1 in 100 live births in France. While incidence remains stable, prevalence is rising due to improved medical care, with cases expected to double by 2050. Despite increased survival, neurological comorbidities remain a major concern, with 40% of patients undergoing childhood cardiac surgery experiencing impairments and 73% presenting MRI-detectable brain lesions postoperatively. These injuries result from congenital heart defects, haemodynamic disturbances, genetic syndromes, and neonatal surgeries with extracorporeal circulation. Some heart defects, such as systemic-to-pulmonary shunts and cyanotic heart diseases, impair cerebral perfusion, increasing the risk of hypoxia and stroke. Mechanical circulatory support systems (e.g. ECMO, cardiopulmonary bypass) also contribute to cerebral risks due to hypoperfusion and clotting complications. Cerebral autoregulation helps maintain stable perfusion despite blood pressure variations. However, bedside cerebral perfusion monitoring remains challenging leading to reliance on indirect methods like near-infrared spectroscopy (NIRS) and transcranial Doppler (TCD), both with limitations. Ultrafast ultrasound (UFUS) is an emerging non-invasive technique that enables real-time quantification of cerebral blood flow, offering new insights into neonatal cerebral haemodynamics.

Interventions

OTHERUltrafast ultrasound (UFUS)

Ultrafast ultrasound imaging(UFUS), ultrasound images at a very high rate, using a Verasonics system (ultrasound open platform).

Sponsors

University Hospital, Bordeaux
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
0 Years to 2 Years
Healthy volunteers
No

Inclusion criteria

* Every patient under 2 years old any sex or gender hospitalised in the congenital heart disease unit of the intensive care and anaesthesia for cardiovascular surgery, CHU de Bordeaux. * Open anterior fontanella * congenital heart disease * cardiac shock necessitating mechanical circulatory support. * Social security affiliation * Parental or legal guardian's non-opposition

Exclusion criteria

* Anechoic * Allergy to echocardiography gel.

Design outcomes

Primary

MeasureTime frameDescription
Cerebral blood volume variationat baselineDepending on stage of medico-surgical treatment

Secondary

MeasureTime frame
Evolution of central venous blood pressureat baseline
Evolution of left atrial pressureat baseline
Evolution of SpO2at baseline
Evolution of SaO2at baseline
Evolution of SvO2at baseline
Evolution of PaCO2at baseline
Evolution of Arterial blood pressureat baseline
Evolution of Hemoglobinemiaat baseline
Inotropic drugs dosagesat baseline
Vasopressive drugs dosagesat baseline
Sedation dosagesat baseline
Analgesia dosagesat baseline
Evolution of PaO2at baseline

Countries

France

Contacts

Primary ContactOlivier VILLEMAIN, MD,PhD
olivier.villemain@chu-bordeaux.fr+33 5 24 54 94 79

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026