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NCT07836244

Predicting the Outcome of ADHD in White Matter Injure Neonates With Multi-modality MRI

Sponsor: First Affiliated Hospital Xi'an Jiaotong University

View on ClinicalTrials.gov

Summary

The goal of this bidirectional observational cohort study is to investigate the longitudinal relationship between neonatal white matter injury (WMI) and the subsequent development of attention-deficit/hyperactivity disorder (ADHD), and to identify early MRI-based markers associated with ADHD-related outcomes. The study includes both retrospective and prospective cohorts to dynamically evaluate the evolution of brain injury, brain development, and behavioral outcomes from infancy to childhood. The main questions it aims to answer are: Are neonatal WMI characteristics associated with the subsequent development of ADHD? Which MRI-derived features, including semi-quantitative WMI assessment, microstructural alterations, and structural disconnection patterns, are associated with ADHD-related outcomes? Participants with neonatal WMI will undergo longitudinal clinical, neurodevelopmental, and behavioral follow-up. Researchers will analyze clinical information and MRI findings to characterize WMI evolution and identify imaging markers associated with ADHD risk. Participants will: undergo brain MRI examinations according to clinical protocols; receive standardized neurodevelopmental and behavioral assessments during follow-up; have MRI-derived measures, including semi-quantitative WMI scores, white matter microstructural features, and structural disconnection measures, analyzed to investigate their associations with ADHD-related outcomes.

Official title: Multi-center Longitudinal Clinical Study on the Evolution of Neonatal White Matter Injure to ADHD Based on Multi-modality MRI

Key Details

Gender

All

Age Range

1 Day - Any

Study Type

OBSERVATIONAL

Enrollment

348

Start Date

2023-01-29

Completion Date

2025-05-30

Last Updated

2026-09-23

Healthy Volunteers

No

Locations (9)

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 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

Hebei Children's Hospital

Shijiazhuang, China

Children's Hospital of Soochow University

Suzhou, China

Wuxi Children's Hospital

Wuxi, China

Northwest Women's and Children's Hospital

Xi'an, China

The Second Affiliated Hospital of Shaanxi University of Chinese Medicine

Xianyang, China