Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
Study NCT ID:
NCT03957512
Status:
COMPLETED
Last Update Posted:
2019-05-22
First Post:
2019-05-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Livet Skal Leves (A Life to Live)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006330', 'term': 'Heart Defects, Congenital'}], 'ancestors': [{'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006348', 'term': 'Cardiac Surgical Procedures'}], 'ancestors': [{'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019616', 'term': 'Thoracic Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3000}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-21', 'studyFirstSubmitDate': '2019-05-18', 'studyFirstSubmitQcDate': '2019-05-20', 'lastUpdatePostDateStruct': {'date': '2019-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '0-2 years', 'description': 'All deaths including prenatal termination of pregnancy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Defects, Congenital']}, 'descriptionModule': {'briefSummary': 'The overall objective of this project is to optimize the use of diagnostic methods and follow-up programs in infants with congenital heart defects (CHDs) in order to reduce death and complications', 'detailedDescription': "The project is designed as retrospective cohort study based on nationwide registry data of children born 2004-16. The project group has extensive experience of similar research, and includes representatives from different fields and levels of health care.\n\nThe results will provide a solid fundament for improvement of today's clinical practice, including development of knowledge-based routines in neonatal medicine and planning of health care services. Implementation is given particular attention, and will be managed in an interdisciplinary setting. The project will be of major relevance for the patients and their families as well as medical professionals at all levels of health care."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '2 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'National population', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Fetuses with severe CHDs who were identified by antenatal ultrasound screening, and where the pregnancy was terminated\n* Children with severe congenital heart defects born in Norway 2004-18\n\nExclusion Criteria:\n\n* Lack of parental consent'}, 'identificationModule': {'nctId': 'NCT03957512', 'briefTitle': 'Livet Skal Leves (A Life to Live)', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Heart Defects in Infants- Detection, Rescue and Care', 'orgStudyIdInfo': {'id': 'REK2010/392'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Heart surgery', 'type': 'PROCEDURE', 'description': 'All invasive procedures'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Oslo', 'country': 'Norway', 'facility': 'Oslo University Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Henrik Holmstrøm, Dr Med', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oslo University Hospital/University of Oslo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Henrik Holmstrøm', 'investigatorAffiliation': 'Oslo University Hospital'}}}}