Quantitative 3D UltraSound Brain Imaging: Development of New Bedside Biomarkers to Better Predict Neurodevelopmental Outcomes in Preterm Infants

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study 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.

Eligibility

Primary outcome measure(s)

• Identifying new early imaging biomarkers to predict NDDs at 2 years of age. — 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.

Trial sites (1)

More Assistance Publique - Hôpitaux de Paris trials in France