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Quantitative 3D UltraSound Brain Imaging: Development of New Bedside Biomarkers to Better Predict Neurodevelopmental Outcomes in Preterm Infants
Sponsor: Assistance Publique - Hôpitaux de Paris
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 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.
Key Details
Gender
All
Age Range
23 Weeks - 35 Weeks
Study Type
INTERVENTIONAL
Enrollment
360
Start Date
2026-04
Completion Date
2031-04
Last Updated
2026-02-18
Healthy Volunteers
No
Interventions
Cranial ultrasound
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 MRI
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 questionnaire
Parent Report of Children's Abilities-Revised (PARCA-R) questionnaire at 2 years
Locations (1)
Hôpital Cochin Port-Royal, APHP Centre
Paris, Île-de-France Region, France