Ignite Creation Date:
2025-12-24 @ 12:56 PM
Ignite Modification Date:
2025-12-27 @ 10:08 PM
Study NCT ID:
NCT00366561
Status:
COMPLETED
Last Update Posted:
2014-12-02
First Post:
2006-08-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neonates With Neurological Complications
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': 810}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-26', 'studyFirstSubmitDate': '2006-08-17', 'studyFirstSubmitQcDate': '2006-08-17', 'lastUpdatePostDateStruct': {'date': '2014-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-08-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The purpose of this study was to examine short term outcomes following cardiac surgery in premature neonates.', 'timeFrame': '6 years', 'description': 'In congenital cardiac defects where there was a choice of palliation vs complete anatomic repair, premature neonates underwent palliative procedures more frequently than term neonates. Premature neonates spent more days of mechanical ventilation compared to their term counterparts. Importantly, there was no difference in mortality between the two groups.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['neonates', 'neurological complications', 'surgery'], 'conditions': ['Congenital Disorders']}, 'descriptionModule': {'briefSummary': "The purpose of this retrospective study is to identify all neonates (newborns \\< 30 days of age) from January 1, 2002 through June 20, 2006 at Children's Healthcare of Atlanta who have suffered neurological complications following cardiac surgery. This retrospective study is important to identify the incidence, care and follow-up of neurological complications at this institution", 'detailedDescription': 'Studies have shown that between one-quarter and one-half of infants undergoing cardiac surgery will suffer brain injury during surgery (the perioperative period). Some infants with congenital heart disease have neurological injury prior to cardiac surgery as a result of cyanosis, acidosis and abnormal circulation. The spectrum of neurological injury ranges from agitation and subtle disturbances in learning and new memory acquisition to visual and motor development abnormalities, seizures, stroke and encephalopathy.\n\nThe patient will be identified from the cardiothoracic surgery database. Their hospital medical records and the neurological database will be reviewed for type of neurological complication (i.e. seizure, stroke), neuro-imaging and any mortality for these patients. We will review the patient outcome data that is available, after the initial surgery, through June 20, 2006. No patients will be contacted.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '30 Days', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "All neonates (newborns \\< 30 days of age) from January 1, 2002 through June 20, 2006 at Children's Healthcare of Atlanta who have suffered neurological complications following cardiac surgery.", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Children's Healthcare of Atlanta patients\n* January 1, 2002 through June 20, 2006\n* \\< 30 days of age\n* neurological complications following cardiac surgery\n\nExclusion Criteria:\n\n* Those who do not meet inclusion criteria"}, 'identificationModule': {'nctId': 'NCT00366561', 'briefTitle': 'Neonates With Neurological Complications', 'organization': {'class': 'OTHER', 'fullName': "Children's Healthcare of Atlanta"}, 'officialTitle': 'Retrospective Review of Neonates With Neurological Complications Following Cardiac Surgery', 'orgStudyIdInfo': {'id': '06-139'}}, '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 M Simsic, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Sibley Heart Center Cardiology at Children's Healthcare of Atlanta"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Healthcare of Atlanta", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}