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Not Yet Recruiting NCT07860749

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

Conditions: Punctate White Matter Lesions, Neurodevelopmental Outcomes, Preterm Infants

Sex: All
Ages: 1 Day – N/A
Healthy volunteers: No
Enrollment: 260
Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Location: First Affiliated Hospital of Xi'an Jiaotong University Xi'an Shaanxi

Summary

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.

Eligibility Criteria

Inclusion Criteria: * Gestational age ≥32 weeks and \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07860749). StuddyBuddy aggregates publicly available trial information.