Very Preterm Infants Born < 30 Weeks of GestationQUSBINCT07358819
Quantitative 3D UltraSound Brain Imaging: Development of New Bedside Biomarkers to Better Predict Neurodevelopmental Outcomes in Preterm Infants
A study testing Cranial ultrasound, Brain MRI and PARCA-R questionnaire in people with Very Preterm Infants Born < 30 Weeks of Gestation, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Prematurity is a leading cause of neurodevelopmental disorders (NDDs) tightly associated with white matter damage, including punctate white matter lesions (PWMLs). Hence, an improved detection of brain injury early in life in infants born very preterm is a top priority to predict NDDs and therefore to assess potential… Read more about this study
- Who is it for?
- Ages 23 to 35 weeks
- Conditions the study is for
- Very Preterm Infants Born < 30 Weeks of Gestation
- What is being tested?
- Cranial ultrasound, Brain MRI and PARCA-R questionnaire
- Type of treatment
- Surgery or procedure
- How many people
- 360 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2026to Apr 2031
- Phase
- Interventional
- 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 23 to 35 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Very preterm infants delivered (either inborn or outborn) between 23+0 and 29+6 weeks of gestation
- Informed written consent of the holders of parental authority.
Who cannot join
- Admission for palliative care
- Chromosomal aberrations and major malformations evidenced after birth Major malformations
- Chromosomal aberrations
- No social security coverage
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
Hôpital Cochin Port-Royal, APHP Centre
Paris, Île-de-France Region, 75014
Olivier BAUD, MD, PhD, 01 58 41 24 23 ext. +33, olivier.baud@aphp.fr
About this study
Prematurity is a leading cause of neurodevelopmental disorders (NDDs) tightly associated with white matter damage, including punctate white matter lesions (PWMLs). Hence, an improved detection of brain injury early in life in infants born very preterm is a top priority to predict NDDs and therefore to assess potential neuroprotective strategies and implement early interventions. 3D and quantitative tools at the bedside using ultrasound are expected to better detect and quantify not only PWMLs but also other brain structures with promising prognostic value to predict NDDs at 2 years of age.
Read the detailed description
Rationale :
Prematurity is a leading cause of neurodevelopmental disorders (NDDs). In Europe, 10% of the 50 000 children born very preterm will develop cerebral palsy and 35% will experience persistent cognitive and neuropsychiatric disorders, including autism, requiring long-term health care support. NDDs following preterm birth are tightly associated with white matter damage, including punctate white matter lesions (PWMLs), a promising marker of subsequent NDDs affecting up to 24% of very preterm infants. Hence, an improved detection of brain injury early in life in infants born very preterm is a top priority to predict NDDs and therefore to assess potential neuroprotective strategies and implement early interventions. Magnetic Resonance Imaging (MRI) is the gold standard to assess white matter integrity and has revealed an association between thalamus structure, ventricular dilatation, white matter damage, and NDDs at preschool age in infants born very preterm. However, it suffers from limited accessibility, low portability, and high sensitivity to motion artifacts mitigating its value for screening in all preterm infants at risk of NDDs. Conversely, conventional 2D cranial ultrasonography (cUS) is a tool widely used in neonatal intensive care units to prospectively screen brain lesions through the anterior fontanel. However, while suitable to detect severe lesions observed in 4-5% of very premature infants only, it remains less reliable for the comprehensive detection of PWMLs despite recent improvements. Hence, 3D and quantitative tools at the bedside using ultrasound must be developed to automatically detect and quantify not only PWMLs but also other brain structures with promising prognostic value.
Main objective:
Identifying new early imaging biomarkers to predict NDDs at 2 years of age.
Primary endpoint:
Correlation between 3D quantification of PWMLs burden collected between day 3±1 and day 21±3, and results of Bayley Scale assessment, 4th edition, French edition (2022) at 2 years of age and the Parent Report of Children's Abilities-Revised (PARCA-R) questionnaire, which identifies preterm children at risk for developmental delays at 24 months of age.
Secondary objectives:
- Developing a processing pipeline allowing the reconstruction of 3D cUS volume \& automatic detection and segmentation algorithms based on deep learning methods.
- Validating these models to detect PWMLs, \& segment thalami and cerebral ventricular system (CVS).
- Correlating thalami and CVS 3D longitudinal volumes in very preterm infants with \& without PWMLs
Secondary endpoints:
- Longitudinal cUS data will allow the generation of standard growth curves for thalami and CVS volumes, stratified by sex and dependent on the concurrent detection of PWMLs.
- Correlation between 3D quantification of PWMLs burden collected between day 3±1 and day 21±3, and results of the Parent Report of Children's Abilities-Revised (PARCA-R) questionnaire. 3D quantification of PWMLs and other 3D cUS tissue segmentations generated using new algorithms developed in WP3 as predictors of (i) MRI findings at term and (ii) neurodevelopmental outcomes at 2 years of age.
Impact :
This project will improve the quality of care by extending advanced quantitative brain imaging to all very preterm infants and improving the early diagnosis of brain injury. It is also expected to promote personalized medicine approaches and support translational research in neuroprotection through the development of new biomarkers for brain injury. Socio-economic impacts include cost reduction through early identification of at-risk children and timely interventions to prevent severe NDD. QUSBI will also have a significant impact on family support.
- Being tested
- Cranial ultrasound, Brain MRI, PARCA-R questionnaire
- Keywords
- Very preterm infants, White matter lesions, Neurodevelopment, 3D Cranial Ultrasound, Artificial intelligence, Prediction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cranial ultrasoundRadiation
Dynamic recording of cranial ultrasound assessment with AI-assisted post-processing for brain segmentation at day 3±1, day 8±2, day 21±3, 36 weeks of postmenstrual age, and term equivalent age using bedside cUS.
Brain MRIRadiation
Brain MRI at term equivalent of age for all neonates (considered as standard of care for those born before 28 weeks of gestation)
PARCA-R questionnaireOther
Parent Report of Children's Abilities-Revised (PARCA-R) questionnaire at 2 years
What is being measured
The primary outcome is the main question the study is designed to answer.
Identifying new early imaging biomarkers to predict NDDs at 2 years of age.
Correlation between 3D quantification of PWMLs burden, and results of Bayley Scale assessment, at 2 years of age and the Parent Report of Children's Abilities-Revised (PARCA-R) questionnaire, which identifies preterm children at risk for developmental delays at 24 months of age.
Measured: 2 years
Secondary outcomes (3)
Developing a processing pipeline allowing the reconstruction of 3D cUS volume & automatic detection and segmentation algorithms based on deep learning methods.
Longitudinal cUS data will allow the generation of standard growth curves for thalami and CVS volumes, stratified by sex and dependent on the concurrent detection of PWMLs
Measured: Between day 3±1 and day 21±3
Validating these models to detect PWMLs, & segment thalami and cerebral ventricular system (CVS).
Correlation between 3D quantification of PWMLs burden collected between between day 3±1 and day 21±3 , day 3±1 and term equivalent age, and results of the Parent Report of Children's Abilities-Revised (PARCA-R) questionnaire.
Measured: 2 years
Correlating thalami and CVS 3D longitudinal volumes in very preterm infants with & without PWMLs
3D quantification of PWMLs and other 3D cUS tissue segmentations generated using new algorithms developed in WP3 as predictors of (i) MRI findings at term and (ii) neurodevelopmental outcomes at 2 years of age
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study startApr 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionApr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Very Preterm Infants Born < 30 Weeks of GestationStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Olivier BAUD, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07358819
- Sponsor's protocol ID
- APHP251518
- Other IDs
- IDRCB
- Acronym
- QUSBI
- Status last verified
- Feb 2026
- First submitted
- 14 Jan 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative 3D UltraSound Brain Imaging: Development of New Bedside Biomarkers to Better Predict Neurodevelopmental Outcomes in Preterm Infants
- ClinicalTrials.gov ID
- NCT07358819
- Acronym / sponsor ID
- QUSBI / APHP251518
- Keywords
- Very preterm infants, White matter lesions, Neurodevelopment, 3D Cranial Ultrasound, Artificial intelligence, Prediction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- Apr 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Apr 2031 (estimated)
- First posted
- 22 Jan 2026 (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.
Prematurity is a leading cause of neurodevelopmental disorders (NDDs) tightly associated with white matter damage, including punctate white matter lesions (PWMLs). Hence, an improved detection of brain injury early in life in infants born very preterm is a top priority to predict NDDs and therefore to assess potential neuroprotective strategies and implement early interventions. 3D and quantitative tools at the bedside using ultrasound are expected to better detect and quantify not only PWMLs but also other brain structures with promising prognostic value to predict NDDs at 2 years of age.
Detailed description
Rationale :
Prematurity is a leading cause of neurodevelopmental disorders (NDDs). In Europe, 10% of the 50 000 children born very preterm will develop cerebral palsy and 35% will experience persistent cognitive and neuropsychiatric disorders, including autism, requiring long-term health care support. NDDs following preterm birth are tightly associated with white matter damage, including punctate white matter lesions (PWMLs), a promising marker of subsequent NDDs affecting up to 24% of very preterm infants. Hence, an improved detection of brain injury early in life in infants born very preterm is a top priority to predict NDDs and therefore to assess potential neuroprotective strategies and implement early interventions. Magnetic Resonance Imaging (MRI) is the gold standard to assess white matter integrity and has revealed an association between thalamus structure, ventricular dilatation, white matter damage, and NDDs at preschool age in infants born very preterm. However, it suffers from limited accessibility, low portability, and high sensitivity to motion artifacts mitigating its value for screening in all preterm infants at risk of NDDs. Conversely, conventional 2D cranial ultrasonography (cUS) is a tool widely used in neonatal intensive care units to prospectively screen brain lesions through the anterior fontanel. However, while suitable to detect severe lesions observed in 4-5% of very premature infants only, it remains less reliable for the comprehensive detection of PWMLs despite recent improvements. Hence, 3D and quantitative tools at the bedside using ultrasound must be developed to automatically detect and quantify not only PWMLs but also other brain structures with promising prognostic value.
Main objective:
Identifying new early imaging biomarkers to predict NDDs at 2 years of age.
Primary endpoint:
Correlation between 3D quantification of PWMLs burden collected between day 3±1 and day 21±3, and results of Bayley Scale assessment, 4th edition, French edition (2022) at 2 years of age and the Parent Report of Children's Abilities-Revised (PARCA-R) questionnaire, which identifies preterm children at risk for developmental delays at 24 months of age.
Secondary objectives:
- Developing a processing pipeline allowing the reconstruction of 3D cUS volume \& automatic detection and segmentation algorithms based on deep learning methods.
- Validating these models to detect PWMLs, \& segment thalami and cerebral ventricular system (CVS).
- Correlating thalami and CVS 3D longitudinal volumes in very preterm infants with \& without PWMLs
Secondary endpoints:
- Longitudinal cUS data will allow the generation of standard growth curves for thalami and CVS volumes, stratified by sex and dependent on the concurrent detection of PWMLs.
- Correlation between 3D quantification of PWMLs burden collected between day 3±1 and day 21±3, and results of the Parent Report of Children's Abilities-Revised (PARCA-R) questionnaire. 3D quantification of PWMLs and other 3D cUS tissue segmentations generated using new algorithms developed in WP3 as predictors of (i) MRI findings at term and (ii) neurodevelopmental outcomes at 2 years of age.
Impact :
This project will improve the quality of care by extending advanced quantitative brain imaging to all very preterm infants and improving the early diagnosis of brain injury. It is also expected to promote personalized medicine approaches and support translational research in neuroprotection through the development of new biomarkers for brain injury. Socio-economic impacts include cost reduction through early identification of at-risk children and timely interventions to prevent severe NDD. QUSBI will also have a significant impact on family support.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 23 to 35 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Very preterm infants delivered (either inborn or outborn) between 23+0 and 29+6 weeks of gestation
- Informed written consent of the holders of parental authority.
Key exclusion criteria (4 listed)
- Admission for palliative care
- Chromosomal aberrations and major malformations evidenced after birth Major malformations
- Chromosomal aberrations
- No social security coverage
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 |
|---|---|---|
| Cranial ultrasoundDynamic recording of cranial ultrasound assessment with AI-assisted post-processing for brain segmentation at day 3±1, day 8±2, day 21±3, 36 weeks of postmenstrual age, and term equivalent age using bedside cUS. | Radiation | – |
| Brain MRIBrain MRI at term equivalent of age for all neonates (considered as standard of care for those born before 28 weeks of gestation) | Radiation | – |
| PARCA-R questionnaireParent Report of Children's Abilities-Revised (PARCA-R) questionnaire at 2 years | Other | – |
Primary outcome
Identifying new early imaging biomarkers to predict NDDs at 2 years of age.
Time frame: 2 years
Correlation between 3D quantification of PWMLs burden, and results of Bayley Scale assessment, at 2 years of age and the Parent Report of Children's Abilities-Revised (PARCA-R) questionnaire, which identifies preterm children at risk for developmental delays at 24 months of age.
3 secondary outcomes
Developing a processing pipeline allowing the reconstruction of 3D cUS volume & automatic detection and segmentation algorithms based on deep learning methods.
Time frame: Between day 3±1 and day 21±3
Validating these models to detect PWMLs, & segment thalami and cerebral ventricular system (CVS).
Time frame: 2 years
Correlating thalami and CVS 3D longitudinal volumes in very preterm infants with & without PWMLs
Time frame: 2 years
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 18 Feb 2026.
- Individual participant dataSharing planned: No
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.
Olivier BAUD, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cranial ultrasound, Brain MRI and PARCA-R questionnaire in people with Very Preterm Infants Born < 30 Weeks of Gestation, run by Assistance Publique - Hôpitaux de Paris 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 2 inclusion and 4 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 18 Feb 2026. 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 BAUD, MD, PhD (01 58 41 24 23 ext. +33, olivier.baud@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identifying new early imaging biomarkers to predict NDDs at 2 years of age. (time frame: 2 years). 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 18 Feb 2026.