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

Mortality Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05075486
• Other study ID #: CQI-RMSIH
• Status: Withdrawn
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2024
• Source: Children's Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Hour to 1 Month

Eligibility

Inclusion Criteria:

• =28 days of life
• receive ECLS support

Exclusion Criteria:

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University	Chinese Neonatal Network

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mortality	Incidence of infants who died during hospitalization	From admission to discharge or death, an average of 3 months
Secondary	Incidence of severe ICH	Proportion of infants who have severe ICH during hospitalization	From admission to discharge or death, an average of 3 months
Secondary	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
Secondary	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