Ignite Creation Date:
2025-12-24 @ 3:55 PM
Ignite Modification Date:
2026-01-03 @ 9:48 PM
Study NCT ID:
NCT00277992
Status:
TERMINATED
Last Update Posted:
2007-05-23
First Post:
2006-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Growth in Children With HLHS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'DEFINED_POPULATION'}, 'enrollmentInfo': {'count': 100}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2001-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-05', 'lastUpdateSubmitDate': '2007-05-22', 'studyFirstSubmitDate': '2006-01-13', 'studyFirstSubmitQcDate': '2006-01-13', 'lastUpdatePostDateStruct': {'date': '2007-05-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-01-18', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Pediatric', 'Cardiac', 'Norwood operation modification', 'GT/Nissen operation', 'Po feed', 'GT fed'], 'conditions': ['Congenital Disorders']}, 'descriptionModule': {'briefSummary': 'Children with HLHS have a history of poor enteral intake and growth. Over the past several years a modification to the Norwood operation was instituted (RV to PA shunt in place of the standard Blalock-Taussig shunt).\n\nThe purpose of this study is to evaluate whether children who underwent this modification of the Norwood procedure had improved growth compared to those in past years who underwent traditional Norwood.', 'detailedDescription': 'The purpose of this study is to evaluate whether children who underwent this modification of the Norwood procedure had improved growth compared to those in past years who underwent traditional Norwood. Also, the standard of care has changed to GT/Nissen operation to facilitate "safe" feeding in those patients who are not able to feed by mouth (po feed).\n\nA second aim of this study is to evaluate whether children who are GT fed have improved growth compared to those who are not.\n\nWe wish to review all patients who underwent Norwood procedure from January 1, 2001 to March 31, 2005.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient at Children's Healthcare of Atlanta, Egleston Norwood procedure between Jan. 1. 2001 and March 31.2005\n\nExclusion Criteria:\n\n* Those who do not meet inclusion criteria"}, 'identificationModule': {'nctId': 'NCT00277992', 'briefTitle': 'Growth in Children With HLHS', 'organization': {'class': 'OTHER', 'fullName': "Children's Healthcare of Atlanta"}, 'officialTitle': 'Growth in Children With HLHS', 'orgStudyIdInfo': {'id': '05-107'}}, 'contactsLocationsModule': {'locations': [{'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': "Children's Healthcare of Atlanta", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'overallOfficials': [{'name': 'Janet Simsic, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Healthcare of Atlanta, Sibley Heat Center Cardiology"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Healthcare of Atlanta", 'class': 'OTHER'}}}}