Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2026-02-22 @ 6:47 PM
Study NCT ID:
NCT02026557
Status:
COMPLETED
Last Update Posted:
2017-07-26
First Post:
2013-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mortality Among Children With Congenital Heart Defects in Norway
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1994-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-24', 'studyFirstSubmitDate': '2013-07-02', 'studyFirstSubmitQcDate': '2013-12-31', 'lastUpdatePostDateStruct': {'date': '2017-07-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of death until 31 dec 2012 among Norwegian children with congenital heart defects born 1994-2009', 'timeFrame': '31.12.2010'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Congenital Heart Disease']}, 'referencesModule': {'references': [{'pmid': '27091847', 'type': 'DERIVED', 'citation': 'Jortveit J, Leirgul E, Eskedal L, Greve G, Fomina T, Dohlen G, Tell GS, Birkeland S, Oyen N, Holmstrom H. Mortality and complications in 3495 children with isolated ventricular septal defects. Arch Dis Child. 2016 Sep;101(9):808-13. doi: 10.1136/archdischild-2015-310154. Epub 2016 Apr 18.'}]}, 'descriptionModule': {'briefSummary': 'To describe mortality among children with congenital heart defects in Norway'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Oslo University hospital´s registry of patients with congenital heart diseases', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* children with congenital heart defects\n\nExclusion Criteria:\n\n* no'}, 'identificationModule': {'nctId': 'NCT02026557', 'briefTitle': 'Mortality Among Children With Congenital Heart Defects in Norway', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sorlandet Hospital HF'}, 'officialTitle': 'Mortality Among Children With Congenital Heart Defects in Norway', 'orgStudyIdInfo': {'id': '2010/392'}}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jarle Jortveit, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sorlandet Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sorlandet Hospital HF', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'University of Oslo', 'class': 'OTHER'}, {'name': 'University of Bergen', 'class': 'OTHER'}, {'name': 'Oslo University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}