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NOT YET RECRUITING
NCT07358819
NA

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

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

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

RADIATION

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.

RADIATION

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)

OTHER

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