Extracorporeal Life SupportNCT05075486
Quality Improvement to Reduce Mortality or Severe Intracranial Hemorrhage in Neonatal Extracorporeal Life Support
A study testing Collaborative quality improvement in people with Extracorporeal Life Support and Extracorporeal Membrane Oxygenation, run by Children's Hospital of Fudan University.
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. Read more about this study
- Who is it for?
- Ages 1 hour to 1 month
- Conditions the study is for
- Extracorporeal Life Support, Extracorporeal Membrane Oxygenation, Quality Improvement
- What is being tested?
- Collaborative quality improvement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 hour to 1 month
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ≤28 days of life
- receive ECLS support
Who cannot join
- Infants with severe congenital anomalies
- Infants with pre-ECLS ICH
About this study
Official title: 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.
Read the 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.
- Conditions
- Extracorporeal Life Support, Extracorporeal Membrane Oxygenation, Quality Improvement, Intracranial Hemorrhage, Mortality, Neonate
- Being tested
- Collaborative quality improvement
- Medical subject headings
- Intracranial Hemorrhages
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collaborative quality improvementBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Group who recieve collaborative quality improvement during study period. Receives: Behavioral: Collaborative quality improvement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From admission to discharge or death, an average of 3 months
Secondary outcomes (4)
Mortality
Incidence of infants who died during hospitalization
Measured: From admission to discharge or death, an average of 3 months
Incidence of severe ICH
Proportion of infants who have severe ICH during hospitalization
Measured: 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
Measured: 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.
Measured: From admission to discharge or death, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2021
- Study start1 Jan 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extracorporeal Life SupportStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a pre- and post- interventional study in one group.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese Neonatal Network
- Responsible party
- Sponsor
- Investigators
- Yun Cao, Principal investigator, Children's Hospital of Fudan University, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05075486
- Sponsor's protocol ID
- CQI-RMSIH
- Status last verified
- Jan 2024
- First submitted
- 6 Sep 2021
- Last updated
- 16 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collaborative Quality Improvement to Reduce Mortality or Severe Intracranial Hemorrhage in Neonatal Extracorporeal Life Support in China
- ClinicalTrials.gov ID
- NCT05075486
- Acronym / sponsor ID
- CQI-RMSIH
- Conditions
- Extracorporeal Life Support, Extracorporeal Membrane Oxygenation, Quality Improvement, Intracranial Hemorrhage, Mortality, Neonate
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Collaborators
- Chinese Neonatal Network
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 12 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a pre- and post- interventional study in one group.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Collaborative quality improvementGroup who recieve collaborative quality improvement during study period. |
Who may qualify
- Ages
- 1 hour to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- ≤28 days of life
- receive ECLS support
Key exclusion criteria (2 listed)
- Infants with severe congenital anomalies
- Infants with pre-ECLS ICH
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collaborative quality improvementHospitals 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. | Behavioural | Intervention group |
Primary outcome
Mortality or severe intracranial hemorrhage (ICH) before discharge
Time frame: From admission to discharge or death, an average of 3 months
It is a binary variable (1/0). The variable would be set into "1", if death or severe ICH occurred
4 secondary outcomes
Mortality
Time frame: From admission to discharge or death, an average of 3 months
Incidence of severe ICH
Time frame: From admission to discharge or death, an average of 3 months
Incidence of successful decannulation of extracorporeal life support
Time frame: From admission to discharge or death, an average of 3 months
Incidences of ECLS related complications
Time frame: From admission to discharge or death, an average of 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yun Cao principal investigator
Children's Hospital of Fudan University, Shanghai, China
Questions about this trial
What is this clinical trial studying?
A study testing Collaborative quality improvement in people with Extracorporeal Life Support and Extracorporeal Membrane Oxygenation, run by Children's Hospital of Fudan University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality or severe intracranial hemorrhage (ICH) before discharge (time frame: From admission to discharge or death, an average of 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2024.