Clinical trial NCT05075486: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Extracorporeal Life Support
Extracorporeal Membrane Oxygenation
Quality Improvement
Intracranial Hemorrhage
Mortality
Neonate
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
Collaborators: name: Chinese Neonatal Network
First posted: 2021-10-12
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a pre- and post- interventional study in one group.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* ≤28 days of life
* receive ECLS support

Exclusion Criteria:

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

Primary outcomes:
measure: Mortality or severe intracranial hemorrhage (ICH) before discharge
timeFrame: From admission to discharge or death, an average of 3 months
Secondary outcomes:
measure: Mortality
timeFrame: From admission to discharge or death, an average of 3 months
measure: Incidence of severe ICH
timeFrame: From admission to discharge or death, an average of 3 months
measure: Incidence of successful decannulation of extracorporeal life support
timeFrame: From admission to discharge or death, an average of 3 months
measure: Incidences of ECLS related complications
timeFrame: From admission to discharge or death, an average of 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Children's Hospital of Fudan University, Shanghai, China
name: Yun Cao
role: PRINCIPAL_INVESTIGATOR
References: