Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2025-12-26 @ 10:08 AM
Study NCT ID:
NCT05045092
Status:
WITHDRAWN
Last Update Posted:
2024-01-16
First Post:
2021-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Follow-up Study of Neonates Receiving Extracorporeal Life Support in China
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'lack of funding', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2024-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-11', 'studyFirstSubmitDate': '2021-09-06', 'studyFirstSubmitQcDate': '2021-09-06', 'lastUpdatePostDateStruct': {'date': '2024-01-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality or severe/moderate neurodevelopmental delay at two-year old', 'timeFrame': 'At two-year old', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Body weight of infants at six months', 'timeFrame': 'At six months'}, {'measure': 'Length of infants at six months', 'timeFrame': 'At six months'}, {'measure': 'Head circumference of infants at six months', 'timeFrame': 'At six months'}, {'measure': 'Body weight of infants at one year old', 'timeFrame': 'At one year old'}, {'measure': 'Length of infants at one year old', 'timeFrame': 'At one year old'}, {'measure': 'Head circumference of infants at one year old', 'timeFrame': 'At one year old'}, {'measure': 'Body weight of infants at two years old', 'timeFrame': 'At two years old'}, {'measure': 'Length of infants at two years old', 'timeFrame': 'At two years old'}, {'measure': 'Head circumference of infants at two years old', 'timeFrame': 'At two years old'}, {'measure': 'Severe/moderate neurodevelopmental delay at six months', 'timeFrame': 'At six months', 'description': 'Proportion of infants with severe/moderate neurodevelopmental delay according to the development scale'}, {'measure': 'Severe/moderate neurodevelopmental delay at one year old', 'timeFrame': 'At one year old', 'description': 'Proportion of infants with severe/moderate neurodevelopmental delay according to the development scale'}, {'measure': 'Severe/moderate neurodevelopmental delay at two years old', 'timeFrame': 'At two years old', 'description': 'Proportion of infants with severe/moderate neurodevelopmental delay according to the development scale'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Extracorporeal Life Support', 'Neurodevelopment', 'Neonate', 'Mortality', 'Extracorporeal Membrane Oxygenation']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Month', 'minimumAge': '1 Hour', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Neonates who receive ECLS support within 28 days of life and survive to the first discharge.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infants who receive extracorporeal life support (ECLS) at ≤28 days of life from 2022.1.1-2023.12.31\n* Survive to the first ICU discharge\n\nExclusion Criteria:\n\n* Infants who died during the ECLS hospitalization\n* Parental refusal to follow-up'}, 'identificationModule': {'nctId': 'NCT05045092', 'briefTitle': 'A Follow-up Study of Neonates Receiving Extracorporeal Life Support in China', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital of Fudan University"}, 'officialTitle': 'A Follow-up Study of Neonates Receiving Extracorporeal Life Support in China', 'orgStudyIdInfo': {'id': 'F-NELS'}}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Yun Cao, Ph.D, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital of Fudan University, Shanghai, China"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital of Fudan University", 'class': 'OTHER'}, 'collaborators': [{'name': 'Chinese Neonatal Network', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}