ECMO Treatment of Children in China in the Past 10 Years | NCT04709432

Studies
ECMO Treatment of Children in China in the Past 10 Years

NCT04709432

Sponsor

Children's Hospital of Fudan University

Status

Recruiting

Last Update Posted

Mar 16, 2026Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Extracorporeal Membrane Oxygenation
Child, Only

Interventions

ECMO

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 11, 2021Actual

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Jan 13, 2021

First Submission Date that Met QC Criteria

Jan 13, 2021

First Posted Date

Jan 14, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 13, 2026

Last Update Posted Date

Mar 16, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ECMO group		children supported by ECMO in the past 10 years	Procedure: ECMO

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ECMO	Procedure	ECMO is a form of Extracorporeal Life Support (ECLS) to support either the pulmonary, or both the pulmonary and cardiac systems.	ECMO group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
survival rate	survival rate after discharge	from admission to discharge （about 10days）

Secondary Outcomes

Measure	Description	Time Frame
time of running ECMO	the total time of running ECMO	from admission to discharge（about 10days）
cost of ECMO treatment	the total cost of ECMO treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age of 1d to 18 years old;
children supported by ECMO in mainland China in the past 10 years

Exclusion Criteria:

none

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

children supported by ECMO in mainland China in the past years

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
YING JIAYUN	Contact	18817583962		jiayundoctor@163.com

Overall Officials

Name	Affiliation	Role
Lu Guoping	Children's Hospital of Fudan University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's Hospital of Fudan University	Recruiting	Shanghai	Shanghai Municipality		China