Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-26 @ 12:44 AM
Study NCT ID:
NCT00268060
Status:
TERMINATED
Last Update Posted:
2007-05-07
First Post:
2005-12-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Infant Medical Records: Case Report Proposal
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D008133', 'term': 'Long QT Syndrome'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'DEFINED_POPULATION'}, 'enrollmentInfo': {'count': 1}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2004-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-05', 'lastUpdateSubmitDate': '2007-05-03', 'studyFirstSubmitDate': '2005-12-20', 'studyFirstSubmitQcDate': '2005-12-20', 'lastUpdatePostDateStruct': {'date': '2007-05-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-12-22', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['pediatric', 'cardiac', 'Long QT Syndrome', 'Pacemaker', 'Herg mutation'], 'conditions': ['Congenital Disorders']}, 'descriptionModule': {'briefSummary': 'Infants with congenital long QT syndrome (LQTS) and 2:1 atrioventricular block (AVB) have been recognized as a clinical subset of children with LQTS.\n\nThe purpose of this study is to describe the clinical course and outcome of a patient with congenital long QT syndrome (LQTS).', 'detailedDescription': "It has been previously reported that 2:1 AVB in neonatal LQTS seems preferentially associated with HERG mutations . It has also been reported in association with the SCN5A gene. We report on a neonate with congenital LQTS and congenital complete heart block who experienced frequent episodes of torades des pointe and ventricular tachycardia, which, over the first 2 days of life, was recalcitrant to traditional therapy of beta-blockers and other antiarrhythmics. Eventually hypotension necessitated the use of an epinephrine infusion, which halted the ventricular tachyarrhythmias. A pacemaker was implanted once the infant was stable and, currently, he is thriving. Genetic analysis revealed a HERG mutation.\n\nFor this study, we will need access to the infant's inpatient and outpatient medical records at Children's Healthcare of Atlanta at Egleston Children's Hospital and Sibley Heart Center Cardiology to include his age, date of birth, medical record number, inpatient labs, inpatient echo reports, outpatient echo reports, inpatient and outpatient EKG's, inpatient pharmacy records, the results of his genetic analysis, his history and physical, transfer notes, daily progress notes, consultation reports and operative reports from his admission beginning 9/30/04."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Congenital long QT Syndrome single case report\n\nExclusion Criteria:\n\n* Single case report'}, 'identificationModule': {'nctId': 'NCT00268060', 'briefTitle': 'Infant Medical Records: Case Report Proposal', 'organization': {'class': 'OTHER', 'fullName': "Children's Healthcare of Atlanta"}, 'officialTitle': 'Baby R. Case Report Proposal', 'orgStudyIdInfo': {'id': '05-050'}}, 'contactsLocationsModule': {'locations': [{'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': "Chldren's Healthcare of Atlanta", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'overallOfficials': [{'name': 'Tracy Froehlich, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Healthcare of Atlanta"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Healthcare of Atlanta", 'class': 'OTHER'}}}}