Extracorporeal Membrane OxygenationNCT04709432
ECMO Treatment of Children in China in the Past 10 Years
An observational study of Extracorporeal Membrane Oxygenation and Child, Only, run by Children's Hospital of Fudan University at 1 site in China.
Trial summary
It is a cross-sectional study to summarize the extracorporeal membrane oxygenation （ECMO）treatment in children in China. Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Extracorporeal Membrane Oxygenation, Child, Only
- What is being tested?
- ECMO
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 11 Jan 2021to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: children supported by ECMO in mainland China in the past years
Who may be able to join
- age of 1d to 18 years old;
- children supported by ECMO in mainland China in the past 10 years
Who cannot join
- none
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality
Guoping Lu, MD, 18017590817, 13788904150@163.com
About this study
Official title: Extracorporeal Membrane Oxygenation (ECMO) Treatment of Children in Mainland China in the Past 10 Years
It is a cross-sectional study to summarize the extracorporeal membrane oxygenation （ECMO）treatment in children in China.
Read the detailed description
ECMO treatment in children is still in its infancy in China, and it has made considerable progress in recent years. In order to further understand the development of ECMO treatment in critically ill children, the investigator conduct this cross-sectional research through questionnaires. The investigator collect general information of the hospital and ECMO equipment, etiology, compilation, and mode of ECMO.
- Conditions
- Extracorporeal Membrane Oxygenation, Child, Only
- Being tested
- ECMO
- Keywords
- Extracorporeal membrane oxygenation; children; complication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECMOProcedure or surgery
ECMO is a form of Extracorporeal Life Support (ECLS) to support either the pulmonary, or both the pulmonary and cardiac systems.
| Study group | Role | What they receive |
|---|---|---|
| ECMO group | children supported by ECMO in the past 10 years Receives: Procedure: ECMO |
What is being measured
The primary outcome is the main question the study is designed to answer.
survival rate
survival rate after discharge
Measured: from admission to discharge （about 10days）
Secondary outcomes (2)
time of running ECMO
the total time of running ECMO
Measured: from admission to discharge（about 10days）
cost of ECMO treatment
the total cost of ECMO treatment
Measured: from admission to discharge （about 10days）
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start11 Jan 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extracorporeal Membrane OxygenationStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lu Guoping, Study chair, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04709432
- Sponsor's protocol ID
- fdpicu-06
- Status last verified
- Mar 2026
- First submitted
- 13 Jan 2021
- Last updated
- 16 Mar 2026
- 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 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extracorporeal Membrane Oxygenation (ECMO) Treatment of Children in Mainland China in the Past 10 Years
- ClinicalTrials.gov ID
- NCT04709432
- Acronym / sponsor ID
- fdpicu-06
- Conditions
- Extracorporeal Membrane Oxygenation, Child, Only
- Keywords
- Extracorporeal membrane oxygenation; children; complication
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 11 Jan 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 14 Jan 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.
It is a cross-sectional study to summarize the extracorporeal membrane oxygenation （ECMO）treatment in children in China.
Detailed description
ECMO treatment in children is still in its infancy in China, and it has made considerable progress in recent years. In order to further understand the development of ECMO treatment in critically ill children, the investigator conduct this cross-sectional research through questionnaires. The investigator collect general information of the hospital and ECMO equipment, etiology, compilation, and mode of ECMO.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ECMO group | – | Procedure: ECMOchildren supported by ECMO in the past 10 years |
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- children supported by ECMO in mainland China in the past years
Key inclusion criteria (2 listed)
- age of 1d to 18 years old;
- children supported by ECMO in mainland China in the past 10 years
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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECMOECMO is a form of Extracorporeal Life Support (ECLS) to support either the pulmonary, or both the pulmonary and cardiac systems. | Procedure or surgery | ECMO group |
Primary outcome
survival rate
Time frame: from admission to discharge （about 10days）
survival rate after discharge
2 secondary outcomes
time of running ECMO
Time frame: from admission to discharge（about 10days）
cost of ECMO treatment
Time frame: from admission to discharge （about 10days）
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
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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.
Lu Guoping study chair
Children's Hospital of Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Extracorporeal Membrane Oxygenation and Child, Only, run by Children's Hospital of Fudan University at 1 site in China.
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: looking for participants now, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact YING JIAYUN (18817583962, jiayundoctor@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
survival rate (time frame: from admission to discharge （about 10days）). 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 Mar 2026.