Collaborative Quality Improvement to Reduce Mortality or Severe Intracranial Hemorrhage in Neonatal Extracorporeal Life Support in China
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Extracorporeal Life Support
- Sponsor
- Children's Hospital of Fudan University
- Primary Endpoint
- Mortality or severe intracranial hemorrhage (ICH) before discharge
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •≤28 days of life
- •receive ECLS support
Exclusion Criteria
- •Infants with severe congenital anomalies
- •Infants with pre-ECLS ICH
Outcomes
Primary Outcomes
Mortality or severe intracranial hemorrhage (ICH) before discharge
Time Frame: 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
Secondary Outcomes
- 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)