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

NCT07358819 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2026-02-18

No results posted yet for this 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.

Conditions

  • Very Preterm Infants Born < 30 Weeks of Gestation

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

Sponsors & Collaborators

  • URC-CIC Paris Descartes Necker Cochin

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Olivier BAUD, MD, PhD · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
23 Weeks
Max Age
35 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2026-12-31
Completion
2031-04-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07358819 on ClinicalTrials.gov