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临床试验/NCT06575283
NCT06575283尚未招募不适用

Early Prediction of Cerebral Palsy by MRI in Infants With White Matter Injury: a Multicenter Study

First Affiliated Hospital Xi'an Jiaotong University1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2024年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
1,000
试验地点
1
主要终点
Accuracy of the model predicting cerebral palsy

研究概览

简要总结

The goal of this study is to determin the MRI features associated with cerebral palsy and to develop prediction models of pediatric disorders by combining MRI with artificial intelligence.

The main questions it aims to answer are:

  • How to achieve features on conventional MRI associated with cerebral palsy?
  • How to predict the risk of cerebral palsy in infants aged 6 to 2 years based on conventional MRI and deep learning? Researchers will compare characteristics of periventricular white matter injury with cerebral palsy to those without cerebral palsy.

Participants will be asked to provide MRI data, clinical diagnoses information, and follow-up outcomes.

详细描述

Cerebral palsy (CP) is a common group of movement disorders that often results in disability in children. In the context of CP, the importance of early diagnosis is crucial, but current diagnostic modalities often identify cases after the age of 2 years. After initial screening of infants at high risk for CP by behavioral scoring, magnetic resonance imaging (MRI) forms an integral part of the comprehensive evaluation. The training of conventional model of CP risk prediction requires a large investment of time and financial resources. The average sensitivity rate drops to 90%. Up to now, deep learning technology has been widely used in tasks related to image-based disease classification and has shown excellent performance.

Periventricular white matter injury (PVWMI) accounts for the largest proportion of various types of brain injuries in cerebral palsy, and the types of brain injuries in cerebral palsy are rich and complex, posing difficulties and challenges to deep learning models. Therefore, this study focuses on PVWMI, the most common type of cerebral palsy, and uses conventional MRI to develop a deep learning prediction model for CP in infants aged 6 months to 2 years old.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
6 Months 至 2 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Infants and children at high risk of periventricular white matter injury (PVWMI) (gestational age <35 weeks, birth weight <2.6 kg, forceps-assisted delivery/fetal head attraction, Apgar score <7, hypoglycaemia, sepsis, electrolyte disturbances, premature rupture of membranes);
  • Those who underwent MRI at 6 months of age-2 years, including at least T1WI and T2WI sequences;
  • Upon follow-up, the patient's clinical diagnosis: cerebral palsy, other diagnoses that did not develop into cerebral palsy, or inability to confirm the diagnosis).

排除标准

  • Incomplete MRI images or unreadable images due to motion artefacts;
  • Incomplete neurobehavioural assessment data (including: gross motor function).

结局指标

主要结局

Accuracy of the model predicting cerebral palsy

时间窗: From September 2024 to December 2025

Determine the accuracy of PVWMI classification and cerebral palsy prediction. The higher the value, the better the model performance.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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