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MRI-Based Neurodevelopmental Risk Stratification in Infants With White Matter Injury

StatusNot Yet Recruiting
PhaseNot specified
Started
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Record History

  1. Minor Study First Submitted
The goal of this observational study is to develop and evaluate an MRI-based assessment system for predicting neurodevelopmental outcomes in infants with punctate white matter lesions (PWML). This is a multicenter, bidirectional cohort study that includes both a retrospective cohort identified from existing clinical and imaging databases and a prospective cohort of consecutively enrolled participants. The study aims to better understand how MRI findings are associated with later developmental outcomes and to identify imaging markers that may help stratify developmental risk. The main questions it aims to answer are: 1. Which MRI features are associated with adverse neurodevelopmental outcomes in infants with PWML? 2. Can MRI-based quantitative assessment methods provide early risk stratification for neurodevelopmental outcomes in infants with PWML? Participants with PWML diagnosed by brain MRI will be followed and evaluated for neurodevelopmental outcomes. Researchers will analyze clinical information and MRI findings collected from participants to develop and validate prediction models. Participants will: 1. undergo brain MRI examinations according to clinical protocols; 2. receive standardized neurodevelopmental assessments during follow-up; 3. have their MRI findings and developmental outcomes analyzed to identify factors associated with later neurodevelopment.
Trial Details
NCT Number NCT07860749
Lead Sponsor First Affiliated Hospital Xi'an Jiaotong University
Conditions
(from sponsor)
Punctate White Matter Lesions, Neurodevelopmental Outcomes, Preterm Infants
Enrollment 260 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov