Quality Improvement to Reduce Mortality or Severe Intracranial Hemorrhage in Neonatal Extracorporeal Life Support
Primary Purpose
Extracorporeal Life Support, Extracorporeal Membrane Oxygenation, Quality Improvement
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Collaborative quality improvement
Sponsored by
About this trial
This is an interventional treatment trial for Extracorporeal Life Support
Eligibility Criteria
Inclusion Criteria:
- ≤28 days of life
- receive ECLS support
Exclusion Criteria:
- Infants with severe congenital anomalies
- Infants with pre-ECLS ICH
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention group
Arm Description
Group who recieve collaborative quality improvement during study period.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Mortality
Incidence of infants who died during hospitalization
Incidence of severe ICH
Proportion of infants who have severe ICH during hospitalization
Incidence of successful decannulation of extracorporeal life support
Proportion of infants who removed from extracorporeal life support successfully
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.
Full Information
NCT ID
NCT05075486
First Posted
September 6, 2021
Last Updated
August 29, 2023
Sponsor
Children's Hospital of Fudan University
Collaborators
Chinese Neonatal Network
1. Study Identification
Unique Protocol Identification Number
NCT05075486
Brief Title
Quality Improvement to Reduce Mortality or Severe Intracranial Hemorrhage in Neonatal Extracorporeal Life Support
Official Title
Collaborative Quality Improvement to Reduce Mortality or Severe Intracranial Hemorrhage in Neonatal Extracorporeal Life Support in China
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2024 (Anticipated)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Fudan University
Collaborators
Chinese Neonatal Network
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extracorporeal Life Support, Extracorporeal Membrane Oxygenation, Quality Improvement, Intracranial Hemorrhage, Mortality, Neonate
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is a pre- and post- interventional study in one group.
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Group who recieve collaborative quality improvement during study period.
Intervention Type
Behavioral
Intervention Name(s)
Collaborative quality improvement
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mortality or severe intracranial hemorrhage (ICH) before discharge
Description
It is a binary variable (1/0). The variable would be set into "1", if death or severe ICH occurred
Time Frame
From admission to discharge or death, an average of 3 months
Secondary Outcome Measure Information:
Title
Mortality
Description
Incidence of infants who died during hospitalization
Time Frame
From admission to discharge or death, an average of 3 months
Title
Incidence of severe ICH
Description
Proportion of infants who have severe ICH during hospitalization
Time Frame
From admission to discharge or death, an average of 3 months
Title
Incidence of successful decannulation of extracorporeal life support
Description
Proportion of infants who removed from extracorporeal life support successfully
Time Frame
From admission to discharge or death, an average of 3 months
Title
Incidences of ECLS related complications
Description
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.
Time Frame
From admission to discharge or death, an average of 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Hour
Maximum Age & Unit of Time
1 Month
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
≤28 days of life
receive ECLS support
Exclusion Criteria:
Infants with severe congenital anomalies
Infants with pre-ECLS ICH
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yun Cao, Ph.D. M.D.
Phone
+8602164931160
Email
yuncao@fudan.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Siyuan Jiang, Ph.D. M.D.
Phone
+8602164931160
Email
jane1350@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yun Cao
Organizational Affiliation
Children's Hospital of Fudan University, Shanghai, China
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Quality Improvement to Reduce Mortality or Severe Intracranial Hemorrhage in Neonatal Extracorporeal Life Support
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