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

Not Applicable

Withdrawn

• Conditions: Mortality; Extracorporeal Membrane Oxygenation; Neonate; Quality Improvement; Extracorporeal Life Support; Intracranial Hemorrhage
• Interventions: Behavioral: Collaborative quality improvement

• Registration Number: NCT05075486
• Lead Sponsor: Children's Hospital of Fudan University

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.

Study Timeline

• Study First Submitted: 2021-09-06
• Study First Submitted QC: 2021-10-09
• Study First Posted: 2021-10-12
• Status Verified: 2024-01
• Study Start: 2024-01-01
• Last Update Submitted: 2024-01-11
• Last Update Posted: 2024-01-16
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• ≤28 days of life
• receive ECLS support

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention group	Collaborative quality improvement	Group who recieve collaborative quality improvement during study period.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Mortality	From admission to discharge or death, an average of 3 months	Incidence of infants who died during hospitalization
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.