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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
Children's Hospital of Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Extracorporeal Life Support

Eligibility Criteria

1 Hour - 1 Month (Child)All SexesDoes not accept healthy volunteers

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

    First Posted
    September 6, 2021
    Last Updated
    August 29, 2023
    Sponsor
    Children's Hospital of Fudan University
    Collaborators
    Chinese Neonatal Network
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    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

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