Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2026-01-02 @ 12:38 AM
Study NCT ID:
NCT04709432
Status:
RECRUITING
Last Update Posted:
2025-02-20
First Post:
2021-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ECMO Treatment of Children in China in the Past 10 Years
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-18', 'studyFirstSubmitDate': '2021-01-13', 'studyFirstSubmitQcDate': '2021-01-13', 'lastUpdatePostDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'survival rate', 'timeFrame': 'from admission to discharge （about 10days）', 'description': 'survival rate after discharge'}], 'secondaryOutcomes': [{'measure': 'time of running ECMO', 'timeFrame': 'from admission to discharge（about 10days）', 'description': 'the total time of running ECMO'}, {'measure': 'cost of ECMO treatment', 'timeFrame': 'from admission to discharge （about 10days）', 'description': 'the total cost of ECMO treatment'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Extracorporeal membrane oxygenation; children; complication'], 'conditions': ['Extracorporeal Membrane Oxygenation', 'Child, Only']}, 'descriptionModule': {'briefSummary': 'It is a cross-sectional study to summarize the extracorporeal membrane oxygenation （ECMO）treatment in children in China.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Day', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'children supported by ECMO in mainland China in the past years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age of 1d to 18 years old;\n* children supported by ECMO in mainland China in the past 10 years\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT04709432', 'briefTitle': 'ECMO Treatment of Children in China in the Past 10 Years', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital of Fudan University"}, 'officialTitle': 'Extracorporeal Membrane Oxygenation (ECMO) Treatment of Children in Mainland China in the Past 10 Years', 'orgStudyIdInfo': {'id': 'fdpicu-06'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ECMO group', 'description': 'children supported by ECMO in the past 10 years', 'interventionNames': ['Procedure: ECMO']}], 'interventions': [{'name': 'ECMO', 'type': 'PROCEDURE', 'description': 'ECMO is a form of Extracorporeal Life Support (ECLS) to support either the pulmonary, or both the pulmonary and cardiac systems.', 'armGroupLabels': ['ECMO group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guoping Lu, MD', 'role': 'CONTACT', 'email': '13788904150@163.com', 'phone': '18017590817'}], 'facility': "Children's Hospital of Fudan University", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'YING JIAYUN', 'role': 'CONTACT', 'email': 'jiayundoctor@163.com', 'phone': '18817583962'}], 'overallOfficials': [{'name': 'Lu Guoping', 'role': 'STUDY_CHAIR', 'affiliation': "Children's Hospital of Fudan University"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital of Fudan University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}