NCT07299721

Brain Ultrafast Ultrasound Imaging

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: University Hospital, Bordeaux · Academic / Other
• Sex: All
• Age: 0 Years – 2 Years
• Healthy volunteers: Not accepted

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.

Conditions

• CHD - Congenital Heart Disease

Interventions

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

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-01-01
• Completion: 2029-01-01
• First posted: 2025-12-23
• Last updated: 2025-12-23

Locations

1 site across 1 country: France