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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Extracorporeal Life Support, Extracorporeal Membrane Oxygenation, Quality Improvement, Intracranial Hemorrhage, Mortality, Neonate

Intervention / Treatment
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* Behavioral: Collaborative quality improvement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≤28 days of life receive ECLS support Exclusion Criteria: Infants with severe congenital anomalies Infants with pre-ECLS ICH

Ages Eligible for Study
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Minimum Age: 1 Hour
Maximum Age: 1 Month

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: This is a pre- and post- interventional study in one group.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Group who recieve collaborative quality improvement during study period. | Behavioral: Collaborative quality improvement<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality or severe intracranial hemorrhage (ICH) before discharge | It is a binary variable (1/0). The variable would be set into 1, if death or severe ICH occurred | From admission to discharge or death, an average of 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Incidence of infants who died during hospitalization | From admission to discharge or death, an average of 3 months | 
| Incidence of severe ICH | Proportion of infants who have severe ICH during hospitalization | From admission to discharge or death, an average of 3 months | 
| Incidence of successful decannulation of extracorporeal life support | Proportion of infants who removed from extracorporeal life support successfully | From admission to discharge or death, an average of 3 months | 
| Incidences of ECLS related complications | 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. | From admission to discharge or death, an average of 3 months |