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临床试验/NCT02637817
NCT02637817Unknown不适用

MRI-based Biomarkers for the Prognosis Judgement of Punctate White Matter Lesions in Neonates: a Longitudinal Multicenter Study

First Affiliated Hospital Xi'an Jiaotong University1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2016年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
600
试验地点
1
主要终点
Cerebral Palsy

研究概览

简要总结

As a common white matter (WM) disease in preterm neonates, punctate white matter lesion (PWML) frequently leads to the abnormalities of brain development (e.g. the motor, visual and auditory disorders), even to cerebral palsy (CP) and amblyopia during childhood. However, it is lack of certain methods in identifying the prognosis of PWML. Through using various advanced MRI techniques, neuro-behavioral and visual assessments, a multicenter longitudinal study would be conducted to follow-up the PWML neonates with varying spatial-position and degree lesions. Through tracking the variations in WM microstructures from neonate period to childhood (2 years old and 3 years old), this study aims to explore (1) the potential relations between varying PWMLs and motor and visual disorders (2) the relations between WM MRI-metrics and neurodevelopmental assessment results, and thus determine the early biomarkers to identify CP and amblyopia.

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
1 Day 至 28 Days(Child)
性别
All
接受健康志愿者

入选标准

  • (1) Age: 1-28 days (2) PWML (3) High quality MRI scan

排除标准

  • (1) Congenital malformations, infections, metabolic disorders, intraventricular hemorrhage (2) Neonates of mothers with gestational diabetes, hypertension, hypoglycemia and history of alcohol

结局指标

主要结局

Cerebral Palsy

时间窗: At age 2

The enrolled subjects who will be diagnosed as cerebral palsy by clinical examination at age 2.

次要结局

  • Amblyopia or movement disorder(At age 3)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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