CHD - Congenital Heart DiseaseBrain UltrafasNCT07299721
Brain Ultrafast Ultrasound Imaging
An observational study of CHD - Congenital Heart Disease, run by University Hospital, Bordeaux at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 2 years
- Conditions the study is for
- CHD - Congenital Heart Disease
- What is being tested?
- Ultrafast ultrasound (UFUS)
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2026to 1 Jan 2029
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 2 years
- All sexes
- No healthy volunteers
- Child
Study population: Every patient, under two years old, receiving a transcranial Doppler in routine care in our CHD unit of intensive care and anaesthesiology for cardiovascular surgery department.
Who may be able to join
- 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
Who cannot join
- Anechoic
- Allergy to echocardiography gel.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Haut Lévêque Cardiology Hospital
Pessac, France, 33604
Olivier VILLEMAIN, MD,PHD, +33 5 24 54 94 79 ext. +33, olivier.villemain@chu-bordeaux.fr
About this study
Official title: Brain Ultrafast Ultrasound Imaging: Application in Pediatric Cardiology: Brain Ultrafast
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.
Read the 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
- Being tested
- Ultrafast ultrasound (UFUS)
- Keywords
- Congenital Heart Disease, Paediatric, Cardiac Imaging, Ultrafast ultrasounf
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrafast ultrasound (UFUS)Other
Ultrafast ultrasound imaging(UFUS), ultrasound images at a very high rate, using a Verasonics system (ultrasound open platform).
| Study group | Role | What they receive |
|---|---|---|
| Patient receiving a transcranial Doppler | Every patient receiving a transcranial Doppler in routine care in our CHD unit of intensive care and anaesthesiology for cardiovascular surgery department Receives: Other: Ultrafast ultrasound (UFUS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral blood volume variation
Depending on stage of medico-surgical treatment
Measured: at baseline
Cerebral blood volume variation
Depending on hemodynamic or ventilatory situation, and exposure to vasoactive or neuroactive drugs.
Measured: at baseline
Secondary outcomes (13)
Evolution of Arterial blood pressure
Measured: at baseline
Evolution of central venous blood pressure
Measured: at baseline
Evolution of left atrial pressure
Measured: at baseline
Evolution of SpO2
Measured: at baseline
Evolution of SaO2
Measured: at baseline
Evolution of SvO2
Measured: at baseline
Evolution of PaCO2
Measured: at baseline
Evolution of PaO2
Measured: at baseline
Evolution of Hemoglobinemia
Measured: at baseline
Inotropic drugs dosages
Measured: at baseline
Vasopressive drugs dosages
Measured: at baseline
Sedation dosages
Measured: at baseline
Analgesia dosages
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start1 Jan 2026 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CHD - Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07299721
- Sponsor's protocol ID
- CHUBX 2025/28
- Other IDs
- CER-BDX 2025-136
- Acronym
- Brain Ultrafas
- Status last verified
- Dec 2025
- First submitted
- 19 Nov 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Ultrafast Ultrasound Imaging: Application in Pediatric Cardiology: Brain Ultrafast
- ClinicalTrials.gov ID
- NCT07299721
- Acronym / sponsor ID
- Brain Ultrafas / CHUBX 2025/28
- Conditions
- CHD - Congenital Heart Disease
- Keywords
- Congenital Heart Disease, Paediatric, Cardiac Imaging, Ultrafast ultrasounf
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 23 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient receiving a transcranial Doppler | – | Other: Ultrafast ultrasound (UFUS)Every patient receiving a transcranial Doppler in routine care in our CHD unit of intensive care and anaesthesiology for cardiovascular surgery department |
Who may qualify
- Ages
- 0 to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Every patient, under two years old, receiving a transcranial Doppler in routine care in our CHD unit of intensive care and anaesthesiology for cardiovascular surgery department.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Anechoic
- Allergy to echocardiography gel.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrafast ultrasound (UFUS)Ultrafast ultrasound imaging(UFUS), ultrasound images at a very high rate, using a Verasonics system (ultrasound open platform). | Other | Patient receiving a transcranial Doppler |
Primary outcome
Cerebral blood volume variation
Time frame: at baseline
Depending on stage of medico-surgical treatment
Cerebral blood volume variation
Time frame: at baseline
Depending on hemodynamic or ventilatory situation, and exposure to vasoactive or neuroactive drugs.
13 secondary outcomes
Evolution of Arterial blood pressure
Time frame: at baseline
Evolution of central venous blood pressure
Time frame: at baseline
Evolution of left atrial pressure
Time frame: at baseline
Evolution of SpO2
Time frame: at baseline
Evolution of SaO2
Time frame: at baseline
Evolution of SvO2
Time frame: at baseline
Evolution of PaCO2
Time frame: at baseline
Evolution of PaO2
Time frame: at baseline
Evolution of Hemoglobinemia
Time frame: at baseline
Inotropic drugs dosages
Time frame: at baseline
Vasopressive drugs dosages
Time frame: at baseline
Sedation dosages
Time frame: at baseline
Analgesia dosages
Time frame: at baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CHD - Congenital Heart Disease, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Olivier VILLEMAIN, MD,PhD (+33 5 24 54 94 79 ext. +33, olivier.villemain@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral blood volume variation (time frame: at baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.