Chinese Neonatal Extracorporeal Life Support Registry (Chi-NELS)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Overall mortality
研究概览
简要总结
Extracorporeal life support (ECLS), also known as extracorporeal membrane oxygenation (ECMO), is an extracorporeal technique which provides respiratory and cardiac support to patients with respiratory and/or heart failure. Neonates account for a significant proportion of patients requiring ECLS support. While with unique pathophysiology among newborn infants, neonatal ECLS treatment faces different challenges (such as specific indications, anticoagulation, hemodynamic management, high incidences of complications, ect.) from those of elder children or adults. Though neonatal ECMO has been used in developed countries since 1970s, the introduction of neonatal ECMO in China was not reported until 2010s. While on the other hand, there has been a rapid increase of neonatal ECLS cases and centers in China in the past decade with a huge variation of numbers of cases and quality among different centers. Therefore, there is an urgent need to monitor the use and quality of neonatal ECLS in China. The goal of the Chinese Neonatal Extracorporeal Life Support Registry (Chi-NELS) is to maintain a registry of use of ECLS in active neonatal ECLS centers across China, to support quality improvement of neonatal ELCS, clinical research and regulatory agencies.
详细描述
This study aims to establish a neonatal ECLS network of all active ECLS centers in China to facilitate standardization of care and collaborative research. On the basis of the network, this prospective comprehensive registry will enroll all neonates who receive ECLS support in participating centers. The indications, managements, complications and outcomes of neonatal ECLS in China will be described in detail, to monitor the development of neonatal ECLS in China, to identify targets for quality improvement, to assist in reducing mortality and morbidity of neonates requiring ECLS support, and to facilitate innovative clinical researches.
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
- •≤28 days of life
- •receive ECLS support
排除标准
- 未提供
结局指标
主要结局
Overall mortality
时间窗: From admission to discharge or death, an average of 3 months
Mortality during NICU
次要结局
- Incidence of renal failure(From admission to discharge or dealth, an average of 3 months)
- Incidence of CPR required(From admission to discharge or dealth, an average of 3 months)
- Incidence of pulmonary hemorrhage(From admission to discharge or dealth, an average of 3 months)
- Rate of successful weaning from ECLS(From admission to discharge or dealth, an average of 3 months)
- Incidence of hemorrhage(From admission to discharge or dealth, an average of 3 months)
- Incidence of cardiac arrhythmia(From admission to discharge or dealth, an average of 3 months)
- Length of hospital stay(From admission to discharge or dealth, an average of 3 months)
- Length of mechanical ventilation(From admission to discharge or dealth, an average of 3 months)
- Incidence of mechanical complications(During ECLS, an average of 3 months)
- Incidence of brain death(From admission to discharge or dealth, an average of 3 months)
- Incidence of seizure(From admission to discharge or dealth, an average of 3 months)
- Incidence of CNS infarction(From admission to discharge or dealth, an average of 3 months)
- Incidence of pneumothorax(From admission to discharge or dealth, an average of 3 months)
- Incidence of infection(From admission to discharge or dealth, an average of 3 months)
- Incidence of limb ischemia(From admission to discharge or dealth, an average of 3 months)
- Incidence of diffuse ischemia of central nervous system (CNS)(From admission to discharge or dealth, an average of 3 months)
- Incidence of intraventricular hemorrhage(From admission to discharge or dealth, an average of 3 months)
- Incidence of hemolysis(From admission to discharge or dealth, an average of 3 months)
- Cost of hospital stay(From admission to discharge or dealth, an average of 3 months)