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NCT Number: NCT07299721

Brain Ultrafast Ultrasound Imaging

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.

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Key information

Age range

0 year–2 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ultrafast ultrasound (UFUS)

Other

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

Primary outcomes

  1. Cerebral blood volume variation

    Time frame: at baseline

    Depending on stage of medico-surgical treatment

  2. Cerebral blood volume variation

    Time frame: at baseline

    Depending on hemodynamic or ventilatory situation, and exposure to vasoactive or neuroactive drugs.

Secondary outcomes

  1. Evolution of Arterial blood pressure

    Time frame: at baseline

  2. Evolution of central venous blood pressure

    Time frame: at baseline

  3. Evolution of left atrial pressure

    Time frame: at baseline

  4. Evolution of SpO2

    Time frame: at baseline

  5. Evolution of SaO2

    Time frame: at baseline

  6. Evolution of SvO2

    Time frame: at baseline

  7. Evolution of PaCO2

    Time frame: at baseline

  8. Evolution of PaO2

    Time frame: at baseline

  9. Evolution of Hemoglobinemia

    Time frame: at baseline

  10. Inotropic drugs dosages

    Time frame: at baseline

  11. Vasopressive drugs dosages

    Time frame: at baseline

  12. Sedation dosages

    Time frame: at baseline

  13. Analgesia dosages

    Time frame: at baseline

Study contacts

Contact information is provided by the study sponsor or research team.

Olivier VILLEMAIN, MD,PhD

CONTACT

[email protected]

+33 5 24 54 94 79 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

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

Acronym: Brain Ultrafas

Important dates

Study start
2026
Primary completion
2026
Study completion
2029
First posted
Dec 23, 2025
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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