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

NCT05075486 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-01-16

No results posted yet for this study

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.

Conditions

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

Interventions

BEHAVIORAL

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.

Sponsors & Collaborators

  • Chinese Neonatal Network

    collaborator OTHER
  • Children's Hospital of Fudan University

    lead OTHER

Principal Investigators

  • Yun Cao · Children's Hospital of Fudan University, Shanghai, China

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Hour
Max Age
1 Month
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2025-12-31
Completion
2025-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05075486 on ClinicalTrials.gov