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

2026年9月30日 更新者：First Affiliated Hospital Xi'an Jiaotong University

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

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.

研究概览

地位

尚未招聘

条件

研究类型

观察性的

注册 (估计的)

260

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 中国
      • Ankang、中国
        • Ankang Central Hospital
        • 接触：
      • Chengdu、中国
        • Sichuan Provincial Maternity and Child Health Care Hospital
        • 接触：
      • Hangzhou、中国
        • Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University
        • 接触：
      • Lanzhou、中国
        • Gansu Province Maternity and Child Health Hospital
        • 接触：
      • Qinghai、中国
        • Qinghai Red Cross Hospital
        • 接触：
      • Shanghai、中国
        • Shanghai Children's Hospital, School of Medicine, Shanghai Jiaotong University
        • 接触：
          • Haoxiang Jiang
          • 电话号码：+86 021-5297601
          • 邮箱：wyshzl@126.com
      • Shijiazhuang、中国
        • Hebei Children's Hospital
        • 接触：
      • Suzhou、中国
        • Children's Hospital of Soochow University
        • 接触：
      • Xianyang、中国
        • The Second Affiliated Hospital of Shaanxi University of Chinese Medicine
        • 接触：
    • Shaanxi
      • Xi'an、Shaanxi、中国、710061
        • First Affiliated Hospital of Xi'an Jiaotong University
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

1天 及以上 (孩子、成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

This study includes infants with punctate white matter lesions (PWML) diagnosed by conventional brain MRI. Eligible participants are infants born at a gestational age of ≥32 weeks and <42 weeks who underwent MRI examination at a corrected gestational age of ≤45 weeks. This multicenter observational cohort study includes retrospective and prospective participants. Clinical information, MRI findings, and longitudinal neurodevelopmental outcomes will be collected to investigate MRI-based assessment methods and predictors of adverse neurodevelopmental outcomes.

描述

Inclusion Criteria:

  • Gestational age ≥32 weeks and <42 weeks at birth.
  • Brain MRI performed at a corrected gestational age ≤45 weeks.
  • Punctate white matter lesions (PWML) diagnosed by conventional brain MRI.

Exclusion Criteria:

  • Other confirmed brain lesions, such as severe intracranial hemorrhage or cerebral infarction.
  • Congenital developmental abnormalities.
  • Confirmed genetic or metabolic diseases.
  • Conditions that severely affect MRI assessment or neurological/developmental evaluation.
  • Inability to complete required MRI assessment or follow-up evaluation.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 观测模型：COHORT
  • 时间观点：OTHER

队列和干预

团体/队列
Moderate-to-Late Preterm Infants with PWML

This cohort includes infants born at 32 to less than 37 weeks of gestation with punctate white matter lesions diagnosed by brain MRI. Participants will undergo clinical data collection, MRI assessment, and longitudinal neurodevelopmental follow-up to evaluate developmental outcomes.
Term Infants with PWML

This cohort includes infants born at 37 to less than 42 weeks of gestation with punctate white matter lesions diagnosed by brain MRI. Participants will undergo clinical data collection, MRI assessment, and longitudinal neurodevelopmental follow-up to evaluate developmental outcome

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Adverse neurodevelopmental outcome at 2 Years
大体时间：At 2 Years of Age

The percentage of participants with an adverse neurodevelopmental outcome at 2 years of age will be assessed using standardized developmental assessment tools, including the Bayley Scales of Infant and Toddler Development, Second or Fourth Edition (Bayley-II or Bayley-IV), Gesell Developmental Schedules, or the Children's Neuropsychological Development Scale, according to the assessment tool and version used at each participating center. Adverse neurodevelopmental outcome will be defined according to predefined criteria based on developmental assessment scores in the cognitive, motor, and language domains, when available. MRI-derived measures will be analyzed to characterize the extent and pattern of white matter injury and to evaluate their prognostic value for subsequent neurodevelopmental outcomes. These measures will include lesion burden, semiquantitative MRI metrics, DTI-based measures, and structural disconnection measures derived from multimodal MRI.
At 2 Years of Age

次要结果测量

结果测量
措施说明
大体时间
Cognitive Developmental Outcome
大体时间：At scheduled neurodevelopmental follow-up assessments at 6 months, 1 year, 2 years, and 3-5 years of age

Cognitive development will be assessed using standardized developmental assessment tools, including the Bayley Scales of Infant and Toddler Development, Second or Fourth Edition (Bayley-II or Bayley-IV), Gesell Developmental Schedules, or the Children's Neuropsychological Development Scale, according to the assessment tool and version used at each participating center. Cognitive impairment will be defined according to predefined score thresholds.The prognostic value of MRI-derived metrics for cognitive impairment will be evaluated. These metrics will include PWML burden, lesion distribution, semi-quantitative metrics, DTI-based measures, and structural disconnection measures.
At scheduled neurodevelopmental follow-up assessments at 6 months, 1 year, 2 years, and 3-5 years of age
Motor Developmental Outcome
大体时间：At scheduled neurodevelopmental follow-up assessments at 6 months, 1 year, 2 years, and 3-5 years of age

Motor development will be assessed using standardized developmental assessment tools, including the Bayley Scales of Infant and Toddler Development, Second or Fourth Edition (Bayley-II or Bayley-IV), Gesell Developmental Schedules, or the Children's Neuropsychological Development Scale, according to the assessment tool and version used at each participating center. Motor impairment will be defined according to predefined score thresholds. The prognostic value of MRI-derived metrics for motor impairment will be evaluated. These metrics will include PWML burden, lesion distribution, semi-quantitative metrics, DTI-based measures, and structural disconnection measures.
At scheduled neurodevelopmental follow-up assessments at 6 months, 1 year, 2 years, and 3-5 years of age
Language Developmental Outcome
大体时间：At scheduled neurodevelopmental follow-up assessments at 6 months, 1 year, 2 years, and 3-5 years of age

Language development will be assessed using standardized developmental assessment tools, including the Bayley Scales of Infant and Toddler Development, Fourth Edition (Bayley-IV), Gesell Developmental Schedules, or the Children's Neuropsychological Development Scale, when available and according to the assessment tool and version used at each participating center. Language impairment will be defined according to predefined score thresholds. The prognostic value of MRI-derived metrics for language impairment will be evaluated. These metrics will include PWML burden, lesion distribution, semi-quantitative metrics, DTI-based measures, and structural disconnection measures.
At scheduled neurodevelopmental follow-up assessments at 6 months, 1 year, 2 years, and 3-5 years of age

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

First Affiliated Hospital Xi'an Jiaotong University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年10月1日

初级完成 (估计的)

2029年12月1日

研究完成 (估计的)

2030年12月1日

研究注册日期

首次提交

2026年9月22日

首先提交符合 QC 标准的

2026年9月30日

首次发布 (实际的)

2026年10月6日

研究记录更新

最后更新发布 (实际的)

2026年10月6日

上次提交的符合 QC 标准的更新

2026年9月30日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • MR-61-26-042984

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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