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

NCT05075486 | Withdrawn

• 1 other identifier: CQI-RMSIH
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Mortality

  From admission to discharge or death, an average of 3 months

• Incidence of severe ICH

  From admission to discharge or death, an average of 3 months

• Incidence of successful decannulation of extracorporeal life support

  From admission to discharge or death, an average of 3 months

• Incidences of ECLS related complications

  From admission to discharge or death, an average of 3 months

Study Arms (1)

Intervention group

EXPERIMENTAL

Group who recieve collaborative quality improvement during study period.

Behavioral: Collaborative quality improvement

Interventions

Collaborative quality improvement 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.

Intervention group

Eligibility Criteria

• Age: 1 Hour - 1 Month
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• ≤28 days of life
• receive ECLS support

You may not qualify if:

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

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead
• Chinese Neonatal Network: collaborator

MeSH Terms

Conditions

Intracranial Hemorrhages

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yun Cao

  Children's Hospital of Fudan University, Shanghai, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a pre- and post- interventional study in one group.

Study Record Dates

• First Submitted: September 6, 2021
• First Posted: October 12, 2021
• Study Start: January 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 16, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share