跳至主要内容
临床试验/NCT05075486
NCT05075486撤回不适用

Collaborative Quality Improvement to Reduce Mortality or Severe Intracranial Hemorrhage in Neonatal Extracorporeal Life Support in China

Children's Hospital of Fudan University0 个研究点开始时间: 2024年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
Mortality or severe intracranial hemorrhage (ICH) before discharge

研究概览

简要总结

This is a three-year pre- and post- interventional study to assess the effectiveness of collaborative quality improvement interventions on reducing mortality and severe intracranial hemorrhage (ICH) for neonates receiving extracorporeal life support (ECLS) in China.

详细描述

This is a three-year pre- and post- interventional study from 2022 to 2024. The population of this study will be all neonates who receive ECLS support within 28 days of life in the participating hospitals of Chinese Neonatal Extracorporeal Life Support Registry (Chi-NELS). The intervention will be collaborative quality improvement interventions for each of the participating hospital. Detailed interventions include standardized ECLS data feedback and benchmark, establishment of potential better practice list, training on quality improvement, implementation of practice change using plan-do-study-action cycles, report and monitor of practice change and collaborative learning. The first year will be pre-intervention baseline period and serves as the control period. Collaborative quality improvement interventions will be introduced from the start of the second year and the second and third years will be the intervention period. The primary outcome, which is the incidence of mortality or severe ICH of the third year, will be compared to that of the baseline year.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
1 Hour 至 1 Month(Child)
性别
All
接受健康志愿者

入选标准

  • ≤28 days of life
  • receive ECLS support

排除标准

  • Infants with severe congenital anomalies
  • Infants with pre-ECLS ICH

结局指标

主要结局

Mortality or severe intracranial hemorrhage (ICH) before discharge

时间窗: From admission to discharge or death, an average of 3 months

It is a binary variable (1/0). The variable would be set into "1", if death or severe ICH occurred

次要结局

  • Incidence of severe ICH(From admission to discharge or death, an average of 3 months)
  • Incidence of successful decannulation of extracorporeal life support(From admission to discharge or death, an average of 3 months)
  • Mortality(From admission to discharge or death, an average of 3 months)
  • Incidences of ECLS related complications(From admission to discharge or death, an average of 3 months)

研究者

申办方类型
Other
责任方
Sponsor

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