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NCT07860749

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

Sponsor: First Affiliated Hospital Xi'an Jiaotong University

View on ClinicalTrials.gov

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.

Official title: Multicenter Study for Developing an MRI Assessment System for Neurodevelopmental Risk Stratification in Infants With White Matter Injury

Key Details

Gender

All

Age Range

1 Day - Any

Study Type

OBSERVATIONAL

Enrollment

260

Start Date

2026-10

Completion Date

2030-12

Last Updated

2026-10-06

Healthy Volunteers

No

Locations (10)

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Ankang Central Hospital

Ankang, China

Sichuan Provincial Maternity and Child Health Care Hospital

Chengdu, China

Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University

Hangzhou, China

Gansu Province Maternity and Child Health Hospital

Lanzhou, China

Qinghai Red Cross Hospital

Qinghai, China

Shanghai Children's Hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, China

Hebei Children's Hospital

Shijiazhuang, China

Children's Hospital of Soochow University

Suzhou, China

The Second Affiliated Hospital of Shaanxi University of Chinese Medicine

Xianyang, China