Ignite Creation Date:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2025-12-27 @ 8:48 PM
Study NCT ID:
NCT00229866
Status:
TERMINATED
Last Update Posted:
2011-07-06
First Post:
2005-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feeding After Neonate Surgery Review
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'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'whyStopped': 'sufficient data gathered for study conclusion', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2006-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-07-05', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-28', 'lastUpdatePostDateStruct': {'date': '2011-07-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-30', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['newborn', 'pediatric health', 'Feeding difficulty', 'discharge with a NG tube', 'G-tube placement', 'Nissen fundoplication'], 'conditions': ['Congenital Disorders']}, 'descriptionModule': {'briefSummary': 'The purpose is to determine what factors, if any, lead to delayed feeding, discharge with a NG tube, G-tube placement or Nissen fundoplication.', 'detailedDescription': "The purpose is to determine what factors, if any, lead to delayed feeding, discharge with a NG tube, G-tube placement or Nissen fundoplication. Will review the newborn database (Lumedx as most interested in those children who have never been fed prior to their cardiac surgery. The medical charts will be reviewed at Children's Healthcare of Atlanta at Egleston Hospital. Approximately 90 charts will be reviewed for newborns undergoing surgery in the 2003 calendar year.\n\nThe factors that will be reviewed are pre-op feeding regimen, diagnosis, single vs two ventricle, open vs closed heart procedure, length of bypass, level of hypothermia, circulatory arrest, presence of TEE probe and post-op ventilation."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Neonates who undergo cardiac surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Neonates who undergo cardiac surgery\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT00229866', 'briefTitle': 'Feeding After Neonate Surgery Review', 'organization': {'class': 'OTHER', 'fullName': "Children's Healthcare of Atlanta"}, 'officialTitle': 'Feeding After Neonatal Surgery Chart Review', 'orgStudyIdInfo': {'id': '04-072'}}, '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': 'Brian Kogon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Healthcare of Atlanta", 'class': 'OTHER'}}}}