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

NCT ID: NCT05075486

Last Updated: 2024-01-16

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2025-12-31

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.

Conditions

Extracorporeal Life Support; Extracorporeal Membrane Oxygenation; Quality Improvement; Intracranial Hemorrhage; Mortality; Neonate

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention group

Group who recieve collaborative quality improvement during study period.

Group Type: EXPERIMENTAL

Collaborative quality improvement

Intervention Type: BEHAVIORAL

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.

Interventions

Collaborative 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• ≤28 days of life
• receive ECLS support

Exclusion Criteria

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

• Minimum Eligible Age: 1 Hour
• Maximum Eligible Age: 1 Month
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese Neonatal Network

OTHER

Sponsor Role: collaborator

Children's Hospital of Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yun Cao

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Fudan University, Shanghai, China

Other Identifiers

CQI-RMSIH

Identifier Type: -

Identifier Source: org_study_id