Extracorporeal Life Support, Extracorporeal Membrane Oxygenation, Intracranial Hemorrhage, Mortality, Neonate, Quality Improvement
Conditions
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.
Interventions
BEHAVIORALCollaborative quality improvement
Hospitals will receive standardized center-specific ECLS data report with benchmarking to feedback on their performance. Evidence-based potential better practice list will be established as a reference for all hospitals. During the intervention period, the hospitals will receive training in collaborative quality improvement method and then develop, implement, and document evidence-based practice changes to reduce adverse outcomes of neonatal ECLS treatment. Compliance with practice changes and neonatal outcomes will be monitored. All hospitals will have access to implementation support and collaborative activities.
Sponsors
Chinese Neonatal Network
Children's Hospital of Fudan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a pre- and post- interventional study in one group.
Eligibility
Sex/Gender
ALL
Age
1 Hours to 1 Months
Healthy volunteers
No
Inclusion criteria
* ≤28 days of life * receive ECLS support
Exclusion criteria
* Infants with severe congenital anomalies * Infants with pre-ECLS ICH
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality or severe intracranial hemorrhage (ICH) before discharge | 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
| Measure | Time frame | Description |
|---|---|---|
| Mortality | From admission to discharge or death, an average of 3 months | Incidence of infants who died during hospitalization |
| Incidence of severe ICH | From admission to discharge or death, an average of 3 months | Proportion of infants who have severe ICH during hospitalization |
| Incidence of successful decannulation of extracorporeal life support | From admission to discharge or death, an average of 3 months | Proportion of infants who removed from extracorporeal life support successfully |
| Incidences of ECLS related complications | From admission to discharge or death, an average of 3 months | Complications include mechanical complications, hemorrhage (GI, cannulation site, surgical site), brain death, seizures, CNS diffuse ischemia, CNS infarction, renal failure, CPR required, cardiac arrhythmia, pneumothorax, pulmonary hemorrhage, hemolysis, limb ischemia, and infection. It is a binary variable (1/0). The variable would be set into 1, if any complication occurred. |
Outcome results
None listed