Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2026-02-24 @ 6:00 PM
Study NCT ID:
NCT01996020
Status:
COMPLETED
Last Update Posted:
2015-05-21
First Post:
2013-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Measurement of Cerebral Flow Using Transfontanellar Doppler in Infants Under Cardiopulmonary Bypass
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006323', 'term': 'Heart Arrest'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-19', 'studyFirstSubmitDate': '2013-11-21', 'studyFirstSubmitQcDate': '2013-11-26', 'lastUpdatePostDateStruct': {'date': '2015-05-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cerebral blood flow velocity', 'timeFrame': '6hour', 'description': 'during cardiac surgery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Cardiopulmonary Arrest']}, 'referencesModule': {'references': [{'pmid': '26691513', 'type': 'DERIVED', 'citation': 'Park YH, Song IK, Lee JH, Kim HS, Kim CS, Kim JT. Intraoperative trans-fontanellar cerebral ultrasonography in infants during cardiac surgery under cardiopulmonary bypass: an observational study. J Clin Monit Comput. 2017 Feb;31(1):159-165. doi: 10.1007/s10877-015-9815-3. Epub 2015 Dec 21.'}]}, 'descriptionModule': {'briefSummary': 'Transfontanellar Doppler can measure the velocity at both the carotid artery and the anterior cerebral artery during cardiopulmonary bypass in congenital heart disease patients. This study can provide reference value of appropriate cerebral blood flow velocity during pediatric cardiac surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Year', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'pediatric patients with congenital heart disease scheduled to recieve cardiac surgery under CPB', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. the patients less than 1 year of age undergo congenital heart surgery with cardiopulmonary bypass\n2. written informed consent is obtained from their guardians in accordance with the requirements of the local ethics committee\n\nExclusion Criteria:\n\n1. synostosis\n2. skull abnormality or fracture\n3. epidural hematoma, scalp hematoma'}, 'identificationModule': {'nctId': 'NCT01996020', 'briefTitle': 'Measurement of Cerebral Flow Using Transfontanellar Doppler in Infants Under Cardiopulmonary Bypass', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Intraoperative Trans-fontanel Cerebral Ultrasonography in Infants During Pediatric Cardiac Surgery Under Cardiopulmonary Bypass', 'orgStudyIdInfo': {'id': 'H-1208-018-421'}}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Jin-Tae Kim', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}