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