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临床试验/NCT02831010
NCT02831010已完成不适用

A Multi-Center Cohort Study of Risk Factors and Outcomes of Encephalopathy of Prematurity in China

Children's Hospital of Fudan University14 个研究点 分布在 1 个国家目标入组 761 人开始时间: 2014年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
761
试验地点
14
主要终点
developmental quotient (DQ) on the Gesell Developmental Schedules

研究概览

简要总结

The purpose of this study is to explore the perinatal risk factors of encephalopathy of prematurity and the morbidity of the following neurodevelopmental impairments in preterm infants with gestational age <32 weeks in China.

详细描述

Recent years have witnessed an increase in survival of very or extremely low birth weight infants, with a corresponding increase of attention to encephalopathy of prematurity (EOP) and the following neurological disorders. Studies suggested that hypoxic-ischemic injury and perinatal infection might be the two main risk factors of EOP, including white matter injury, neuronal-axonal diseases and cerebellar hemorrhage, which have a strong impact on neurological outcomes. Sequelae like cerebral palsy or mental retardation become a burden to both the family and society. Therefore, the risk factors of brain injury become the critical issue of both Obstetrics and Neonatology. More importantly, little is known about the morbidity of neurodevelopmental impairment and its risk factors in China. Thus, the aim of our study is to explore the perinatal risk factors of encephalopathy of prematurity and the morbidity of the following neurodevelopmental impairments in preterm infants with gestational age <32 weeks in China.

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
— 至 28 Days(Child)
性别
All
接受健康志愿者

入选标准

  • preterm infants with gestational age less than 32 weeks

排除标准

  • major congenital malformations
  • chromosomal disorders
  • metabolic diseases

结局指标

主要结局

developmental quotient (DQ) on the Gesell Developmental Schedules

时间窗: 2 years

Result of gross motor, fine motor, language and social test. DQ = Development Age / Chronological Age X 100

次要结局

  • brain injury showed on MRI(36-40 weeks' postmenstrual age or before discharge)
  • all cause mortality(2 years)
  • morbidity of encephalopathy of prematurity(36-40 weeks' postmenstrual age or before discharge)
  • neurodevelopment sequelae(2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (14)

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