Extracorporeal Life SupportNCT05045092
A Follow-up Study of Neonates Receiving Extracorporeal Life Support in China
An observational study of Extracorporeal Life Support and Neurodevelopment, run by Children's Hospital of Fudan University.
Trial summary
Descriptive study of two-year follow-up outcomes of surviving neonates who are enrolled in the Chinese Neonatal Extracorporeal Life Support Registry (Chi-NELS) from 2022 to 2024. Read more about this study
- Who is it for?
- Ages 1 hour to 1 month
- Conditions the study is for
- Extracorporeal Life Support, Neurodevelopment, Neonate
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to 31 Dec 2027
- 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: Neonates who receive ECLS support within 28 days of life and survive to the first discharge.
Who may be able to join
- Infants who receive extracorporeal life support (ECLS) at ≤28 days of life from 2022.1.1-2023.12.31
- Survive to the first ICU discharge
Who cannot join
- Infants who died during the ECLS hospitalization
- Parental refusal to follow-up
About this study
Descriptive study of two-year follow-up outcomes of surviving neonates who are enrolled in the Chinese Neonatal Extracorporeal Life Support Registry (Chi-NELS) from 2022 to 2024.
Read the detailed description
This study aims to describe the six -month, one-year and two-year neurodevelopmental outcomes of survivors of neonatal ECLS treatment in the Chi-NELS. The study population will be neonates who receive ECLS support within 28 days of life and are enrolled in the Chi-NELS. These infants will be prospectively followed for two years. Mortality, growth, and neurodevelopmental outcomes will be assessed at six months, one year and two years.
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality or severe/moderate neurodevelopmental delay at two-year old
It is a binary variable (1/0). If mortality or severe/moderate neurodevelopmental delay occur in the participent, the value of this varible is 1.
Measured: At two-year old
Secondary outcomes (12)
Body weight of infants at six months
Measured: At six months
Length of infants at six months
Measured: At six months
Head circumference of infants at six months
Measured: At six months
Body weight of infants at one year old
Measured: At one year old
Length of infants at one year old
Measured: At one year old
Head circumference of infants at one year old
Measured: At one year old
Body weight of infants at two years old
Measured: At two years old
Length of infants at two years old
Measured: At two years old
Head circumference of infants at two years old
Measured: At two years old
Severe/moderate neurodevelopmental delay at six months
Proportion of infants with severe/moderate neurodevelopmental delay according to the development scale
Measured: At six months
Severe/moderate neurodevelopmental delay at one year old
Proportion of infants with severe/moderate neurodevelopmental delay according to the development scale
Measured: At one year old
Severe/moderate neurodevelopmental delay at two years old
Proportion of infants with severe/moderate neurodevelopmental delay according to the development scale
Measured: At two years old
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start1 Jan 2024 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (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)
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, Ph.D, M.D., Principal investigator, Children's Hospital of Fudan University, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05045092
- Sponsor's protocol ID
- F-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
- 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
- A Follow-up Study of Neonates Receiving Extracorporeal Life Support in China
- ClinicalTrials.gov ID
- NCT05045092
- Acronym / sponsor ID
- F-NELS
- Conditions
- Extracorporeal Life Support, Neurodevelopment, Neonate, Mortality, Extracorporeal Membrane Oxygenation
- 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 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 16 Sep 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.
Descriptive study of two-year follow-up outcomes of surviving neonates who are enrolled in the Chinese Neonatal Extracorporeal Life Support Registry (Chi-NELS) from 2022 to 2024.
Detailed description
This study aims to describe the six -month, one-year and two-year neurodevelopmental outcomes of survivors of neonatal ECLS treatment in the Chi-NELS. The study population will be neonates who receive ECLS support within 28 days of life and are enrolled in the Chi-NELS. These infants will be prospectively followed for two years. Mortality, growth, and neurodevelopmental outcomes will be assessed at six months, one year and two years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 hour to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Neonates who receive ECLS support within 28 days of life and survive to the first discharge.
Key inclusion criteria (2 listed)
- Infants who receive extracorporeal life support (ECLS) at ≤28 days of life from 2022.1.1-2023.12.31
- Survive to the first ICU discharge
Key exclusion criteria (2 listed)
- Infants who died during the ECLS hospitalization
- Parental refusal to follow-up
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
Mortality or severe/moderate neurodevelopmental delay at two-year old
Time frame: At two-year old
It is a binary variable (1/0). If mortality or severe/moderate neurodevelopmental delay occur in the participent, the value of this varible is 1.
12 secondary outcomes
Body weight of infants at six months
Time frame: At six months
Length of infants at six months
Time frame: At six months
Head circumference of infants at six months
Time frame: At six months
Body weight of infants at one year old
Time frame: At one year old
Length of infants at one year old
Time frame: At one year old
Head circumference of infants at one year old
Time frame: At one year old
Body weight of infants at two years old
Time frame: At two years old
Length of infants at two years old
Time frame: At two years old
Head circumference of infants at two years old
Time frame: At two years old
Severe/moderate neurodevelopmental delay at six months
Time frame: At six months
Severe/moderate neurodevelopmental delay at one year old
Time frame: At one year old
Severe/moderate neurodevelopmental delay at two years old
Time frame: At two years old
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, Ph.D, M.D. 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 Neurodevelopment, 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/moderate neurodevelopmental delay at two-year old (time frame: At two-year old). 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.