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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Mortality; Extracorporeal Membrane Oxygenation; Quality Improvement; Intracranial Hemorrhage; Extracorporeal Life Support; Neonate
• Intervention / Treatment: Behavioral: Collaborative quality improvement

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 hour to 1 month (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• ≤28 days of life
• receive ECLS support

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intervention group; Group who recieve collaborative quality improvement during study period.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Incidence of infants who died during hospitalization	From admission to discharge or death, an average of 3 months
Incidence of severe ICH	Proportion of infants who have severe ICH during hospitalization	From admission to discharge or death, an average of 3 months
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
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

Collaborators and Investigators

• Sponsor: Children's Hospital of Fudan University
• Collaborators: Chinese Neonatal Network
• Investigators: Principal Investigator: Yun Cao, Children's Hospital of Fudan University, Shanghai, China

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: September 6, 2021
• First Submitted That Met QC Criteria: October 9, 2021
• First Posted (Actual): October 12, 2021

Study Record Updates

• Last Update Posted (Actual): January 16, 2024
• Last Update Submitted That Met QC Criteria: January 11, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hemorrhage; Intracranial Hemorrhages
• Other Study ID Numbers: CQI-RMSIH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No