Extracorporeal Life SupportNCT05085080
Chinese Neonatal Extracorporeal Life Support Registry (Chi-NELS)
An observational study of Extracorporeal Life Support and Neonate, run by Children's Hospital of Fudan University.
Trial summary
Extracorporeal life support (ECLS), also known as extracorporeal membrane oxygenation (ECMO), is an extracorporeal technique which provides respiratory and cardiac support to patients with respiratory and/or heart failure. Neonates account for a significant proportion of patients requiring ECLS support. Read more about this study
- Who is it for?
- Ages 1 hour to 1 month
- Conditions the study is for
- Extracorporeal Life Support, Neonate
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to 31 Dec 2025
- How long will I take part?
- 4 Months
- Phase
- Observational
- 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
Study population: All neonate recieved ECLS support
Who may be able to join
- ≤28 days of life
- receive ECLS support
Who cannot join
- none
About this study
Extracorporeal life support (ECLS), also known as extracorporeal membrane oxygenation (ECMO), is an extracorporeal technique which provides respiratory and cardiac support to patients with respiratory and/or heart failure. Neonates account for a significant proportion of patients requiring ECLS support. While with unique pathophysiology among newborn infants, neonatal ECLS treatment faces different challenges (such as specific indications, anticoagulation, hemodynamic management, high incidences of complications, ect.) from those of elder children or adults. Though neonatal ECMO has been used in developed countries since 1970s, the introduction of neonatal ECMO in China was not reported until 2010s. While on the other hand, there has been a rapid increase of neonatal ECLS cases and centers in China in the past decade with a huge variation of numbers of cases and quality among different centers. Therefore, there is an urgent need to monitor the use and quality of neonatal ECLS in China. The goal of the Chinese Neonatal Extracorporeal Life Support Registry (Chi-NELS) is to maintain a registry of use of ECLS in active neonatal ECLS centers across China, to support quality improvement of neonatal ELCS, clinical research and regulatory agencies.
Read the detailed description
This study aims to establish a neonatal ECLS network of all active ECLS centers in China to facilitate standardization of care and collaborative research. On the basis of the network, this prospective comprehensive registry will enroll all neonates who receive ECLS support in participating centers. The indications, managements, complications and outcomes of neonatal ECLS in China will be described in detail, to monitor the development of neonatal ECLS in China, to identify targets for quality improvement, to assist in reducing mortality and morbidity of neonates requiring ECLS support, and to facilitate innovative clinical researches.
- Conditions
- Extracorporeal Life Support, Neonate
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall mortality
Mortality during NICU
Measured: From admission to discharge or death, an average of 3 months
Secondary outcomes (19)
Rate of successful weaning from ECLS
Proportion of infants who were successfully weaning from ECLS
Measured: From admission to discharge or dealth, an average of 3 months
Incidence of mechanical complications
Complication related to the ECLS circuit
Measured: During ECLS, an average of 3 months
Incidence of hemorrhage
Hemorrhage complication including bleeding at gastrointestinal tract, cannulation site, or surgical site
Measured: From admission to discharge or dealth, an average of 3 months
Incidence of brain death
Brain death is diagnosed according to the definition published on critical care medcine in 2011
Measured: From admission to discharge or dealth, an average of 3 months
Incidence of seizure
Seizure was confirmed by EEG
Measured: From admission to discharge or dealth, an average of 3 months
Incidence of diffuse ischemia of central nervous system (CNS)
Proportion of infants with diffuse ischemia of central nervous system (CNS)
Measured: From admission to discharge or dealth, an average of 3 months
Incidence of CNS infarction
Proportion of infants with CNS infarction
Measured: From admission to discharge or dealth, an average of 3 months
Incidence of intraventricular hemorrhage
Proportion of infants with intraventricular hemorrhage
Measured: From admission to discharge or dealth, an average of 3 months
Incidence of renal failure
Proportion of infants renal failure
Measured: From admission to discharge or dealth, an average of 3 months
Incidence of CPR required
Proportion of infants required CPR
Measured: From admission to discharge or dealth, an average of 3 months
Incidence of cardiac arrhythmia
Proportion of infants with cardiac arrhythmia
Measured: From admission to discharge or dealth, an average of 3 months
Incidence of pneumothorax
Proportion of infants with pneumothorax
Measured: From admission to discharge or dealth, an average of 3 months
Incidence of pulmonary hemorrhage
Proportion of infants with pulmonary hemorrhage
Measured: From admission to discharge or dealth, an average of 3 months
Incidence of hemolysis
Proportion of infants with hemolysis
Measured: From admission to discharge or dealth, an average of 3 months
Incidence of limb ischemia
Proportion of infants limb ischemia
Measured: From admission to discharge or dealth, an average of 3 months
Incidence of infection
Infection include pneumonia, sepsis, urinary tract infection, central nervous system infection etc..
Measured: From admission to discharge or dealth, an average of 3 months
Length of hospital stay
Days of hospitalization
Measured: From admission to discharge or dealth, an average of 3 months
Cost of hospital stay
All costs during hospitallization
Measured: From admission to discharge or dealth, an average of 3 months
Length of mechanical ventilation
Days of mechanical ventilation
Measured: From admission to discharge or dealth, 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 posted20 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 4 Months
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
- NCT05085080
- Sponsor's protocol ID
- Chi-NELS
- 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
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
- Chinese Neonatal Extracorporeal Life Support Registry (Chi-NELS)
- ClinicalTrials.gov ID
- NCT05085080
- Acronym / sponsor ID
- Chi-NELS
- Conditions
- Extracorporeal Life Support, Neonate
- Study type
- Observational
- 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
- 20 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.
Extracorporeal life support (ECLS), also known as extracorporeal membrane oxygenation (ECMO), is an extracorporeal technique which provides respiratory and cardiac support to patients with respiratory and/or heart failure. Neonates account for a significant proportion of patients requiring ECLS support. While with unique pathophysiology among newborn infants, neonatal ECLS treatment faces different challenges (such as specific indications, anticoagulation, hemodynamic management, high incidences of complications, ect.) from those of elder children or adults. Though neonatal ECMO has been used in developed countries since 1970s, the introduction of neonatal ECMO in China was not reported until 2010s. While on the other hand, there has been a rapid increase of neonatal ECLS cases and centers in China in the past decade with a huge variation of numbers of cases and quality among different centers. Therefore, there is an urgent need to monitor the use and quality of neonatal ECLS in China. The goal of the Chinese Neonatal Extracorporeal Life Support Registry (Chi-NELS) is to maintain a registry of use of ECLS in active neonatal ECLS centers across China, to support quality improvement of neonatal ELCS, clinical research and regulatory agencies.
Detailed description
This study aims to establish a neonatal ECLS network of all active ECLS centers in China to facilitate standardization of care and collaborative research. On the basis of the network, this prospective comprehensive registry will enroll all neonates who receive ECLS support in participating centers. The indications, managements, complications and outcomes of neonatal ECLS in China will be described in detail, to monitor the development of neonatal ECLS in China, to identify targets for quality improvement, to assist in reducing mortality and morbidity of neonates requiring ECLS support, and to facilitate innovative clinical researches.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Months
Who may qualify
- Ages
- 1 hour to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All neonate recieved ECLS support
Key inclusion criteria (2 listed)
- ≤28 days of life
- receive ECLS support
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall mortality
Time frame: From admission to discharge or death, an average of 3 months
Mortality during NICU
19 secondary outcomes
Rate of successful weaning from ECLS
Time frame: From admission to discharge or dealth, an average of 3 months
Incidence of mechanical complications
Time frame: During ECLS, an average of 3 months
Incidence of hemorrhage
Time frame: From admission to discharge or dealth, an average of 3 months
Incidence of brain death
Time frame: From admission to discharge or dealth, an average of 3 months
Incidence of seizure
Time frame: From admission to discharge or dealth, an average of 3 months
Incidence of diffuse ischemia of central nervous system (CNS)
Time frame: From admission to discharge or dealth, an average of 3 months
Incidence of CNS infarction
Time frame: From admission to discharge or dealth, an average of 3 months
Incidence of intraventricular hemorrhage
Time frame: From admission to discharge or dealth, an average of 3 months
Incidence of renal failure
Time frame: From admission to discharge or dealth, an average of 3 months
Incidence of CPR required
Time frame: From admission to discharge or dealth, an average of 3 months
Incidence of cardiac arrhythmia
Time frame: From admission to discharge or dealth, an average of 3 months
Incidence of pneumothorax
Time frame: From admission to discharge or dealth, an average of 3 months
Incidence of pulmonary hemorrhage
Time frame: From admission to discharge or dealth, an average of 3 months
Incidence of hemolysis
Time frame: From admission to discharge or dealth, an average of 3 months
Incidence of limb ischemia
Time frame: From admission to discharge or dealth, an average of 3 months
Incidence of infection
Time frame: From admission to discharge or dealth, an average of 3 months
Length of hospital stay
Time frame: From admission to discharge or dealth, an average of 3 months
Cost of hospital stay
Time frame: From admission to discharge or dealth, an average of 3 months
Length of mechanical ventilation
Time frame: From admission to discharge or dealth, 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.
Related trials for Extracorporeal Life Support
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruitingObservational study
Diagnosis of ECMO Cannula Infection: Prospective Comparison of Sampling Methods
ECMO Cannula Infection, Extracorporeal Membrane Oxygenation Complication
RecruitingObservational study
Effect of Transpulmonary MP on Prognosis of Patients With Severe ARDS Treated With VV-ECMO
Acute Respiratory Distress Syndrome, Extracorporeal Membrane Oxygenation
Not yet recruitingPhase 1/2
PACE: Prostacyclin AntiCoagulation in ECMO
ECMO
RecruitingObservational study
Pharmacokinetics of Sedatives and Analgesics During Extracorporeal Membrane Oxygenation (ECMO) Support
Drug Effect
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?
An observational study of Extracorporeal Life Support and Neonate, 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 1 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?
Overall mortality (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.