Multi-center Longitudinal Clinical Study on the Evolution of Neonatal White Matter Injure to ADHD Based on Multi-modality MRI
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 348
- 试验地点
- 9
- 主要终点
- Attention-Deficit/Hyperactivity Disorder (ADHD) Diagnosis
研究概览
简要总结
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.
详细描述
White matter injury (WMI) is a common form of neonatal brain injury and may be associated with altered brain development and later neurodevelopmental disorders. Previous studies have suggested that abnormalities in brain microstructure and connectivity after neonatal WMI may overlap with neural circuits involved in attention and executive function. However, the longitudinal evolution of neonatal WMI and its relationship with the development of attention-deficit/hyperactivity disorder (ADHD) remain incompletely understood.
This bidirectional observational cohort study will investigate the association between neonatal WMI characteristics and later ADHD-related outcomes through longitudinal clinical and neuroimaging follow-up. The study includes retrospective and prospective cohorts to characterize brain developmental trajectories after neonatal WMI.
Multimodal MRI analyses were performed to quantify WMI-related brain alterations, including conventional MRI-based semi-quantitative assessment, white matter microstructural measurements, and structural disconnection analysis. These MRI-derived features were evaluated in relation to subsequent neurodevelopmental and behavioral outcomes to identify early imaging markers associated with ADHD risk.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 1 Day 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neonates diagnosed with white matter injury (WMI) or neonates without obvious abnormalities on routine MRI examination from the multicenter database.
- •Brain MRI examination performed within 28 days after birth, with gestational age ≤42 weeks at examination.
- •Complete MRI data available, including T1-weighted imaging (T1WI), T2-weighted imaging (T2WI), and diffusion tensor imaging (DTI).
- •Complete maternal and pregnancy history information, neonatal demographic characteristics, and clinical information available.
排除标准
- •Congenital nervous system developmental malformations or suspected genetic or metabolic diseases.
- •Obvious MRI artifacts affecting image evaluation.
- •Inability to complete follow-up neurobehavioral assessments.
研究组 & 干预措施
White matter injure group
Neonates presented with punctate, linear, or clustered white matter lesions at the center of the semiovale and lateral ventricles, with TIWI hyper-intensive s and with or without T2WI hypointensity.
Control group
No abnormal signals are found on both conventional and diffusion images. SWI and ASL are also considered when necessary.
结局指标
主要结局
Attention-Deficit/Hyperactivity Disorder (ADHD) Diagnosis
时间窗: At 3-5 years of age
ADHD diagnosis will be determined according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria, combined with standardized behavioral assessment using the Swanson, Nolan, and Pelham (SNAP) questionnaire. The number of participants meeting the diagnostic criteria for ADHD at follow-up will be recorded.
次要结局
- Cognitive Developmental Outcome(During infancy follow-up assessments (6 months to 5 years of age))
- Motor Developmental Outcome(During infancy follow-up assessments (6 months to 5 years of age))