A Follow-up Study of Neonates Receiving Extracorporeal Life Support in China
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Mortality or severe/moderate neurodevelopmental delay at two-year old
研究概览
简要总结
Descriptive study of two-year follow-up outcomes of surviving neonates who are enrolled in the Chinese Neonatal Extracorporeal Life Support Registry (Chi-NELS) from 2022 to 2024.
详细描述
This study aims to describe the six -month, one-year and two-year neurodevelopmental outcomes of survivors of neonatal ECLS treatment in the Chi-NELS. The study population will be neonates who receive ECLS support within 28 days of life and are enrolled in the Chi-NELS. These infants will be prospectively followed for two years. Mortality, growth, and neurodevelopmental outcomes will be assessed at six months, one year and two years.
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 Hour 至 1 Month（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants who receive extracorporeal life support (ECLS) at ≤28 days of life from 2022.1.1-2023.12.31
- •Survive to the first ICU discharge
排除标准
- •Infants who died during the ECLS hospitalization
- •Parental refusal to follow-up
结局指标
主要结局
Mortality or severe/moderate neurodevelopmental delay at two-year old
时间窗: At two-year old
It is a binary variable (1/0). If mortality or severe/moderate neurodevelopmental delay occur in the participent, the value of this varible is 1.
次要结局
- Head circumference of infants at two years old(At two years old)
- Body weight of infants at two years old(At two years old)
- Head circumference of infants at one year old(At one year old)
- Length of infants at two years old(At two years old)
- Severe/moderate neurodevelopmental delay at one year old(At one year old)
- Severe/moderate neurodevelopmental delay at two years old(At two years old)
- Head circumference of infants at six months(At six months)
- Body weight of infants at one year old(At one year old)
- Length of infants at one year old(At one year old)
- Body weight of infants at six months(At six months)
- Length of infants at six months(At six months)
- Severe/moderate neurodevelopmental delay at six months(At six months)