Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2025-12-29 @ 12:32 AM
Study NCT ID:
NCT00728234
Status:
COMPLETED
Last Update Posted:
2008-08-07
First Post:
2008-07-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analysis of Correlation of Amplitude-Integrated EEG and Neurodevelopmental Outcome in Preterm Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 284}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-07', 'completionDateStruct': {'date': '2006-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-08-06', 'studyFirstSubmitDate': '2008-07-31', 'studyFirstSubmitQcDate': '2008-07-31', 'lastUpdatePostDateStruct': {'date': '2008-08-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2002-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'amplitude-integrated electroencephalography tracings of the first weeks of life; obtained on a weekly basis', 'timeFrame': '8-12 weeks'}], 'secondaryOutcomes': [{'measure': 'neurodevelopmental outcome at the age of three years assessed by Bayley Scales of Infant Development', 'timeFrame': 'three years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['aEEG', 'preterm infants', 'predictive value', 'outcome'], 'conditions': ['Brain Activity', 'Neurodevelopmental Outcome']}, 'referencesModule': {'references': [{'pmid': '21436758', 'type': 'DERIVED', 'citation': 'Klebermass K, Olischar M, Waldhoer T, Fuiko R, Pollak A, Weninger M. Amplitude-integrated EEG pattern predicts further outcome in preterm infants. Pediatr Res. 2011 Jul;70(1):102-8. doi: 10.1203/PDR.0b013e31821ba200.'}]}, 'descriptionModule': {'briefSummary': 'The study included analysis of longitudinal recordings of amplitude-integrated EEG (aEEG) tracings on a weekly basis in preterm infants and evaluation of their neurodevelopmental outcome at the age of three years.\n\nAim of the study was to observe if there is a correlation of the aEEG tracings of the first weeks of life to later neurodevelopmental outcome and to evaluate if aEEG can be used as prognostic tool.', 'detailedDescription': 'From the first week of life on aEEG-recordings were obtained on a weekly basis and the results of the first eight weeks of life were analyzed for this study.\n\naEEG-tracings were analyzed with regard to background activity (percentages of continuous and discontinuous patterns), the presence/absence of sleep-wake-cycles and the occurrence of seizure activity. These items where summed up in a score including three grades (normal, moderately and severely abnormal).\n\nThe aEEG was recorded as a single channel EEG from biparietal surface disk electrodes using a CFM (CFM 5330, Lectromed Devices Ltd., UK) or the CFM 6000 (Olympic Medical, USA). Assessment of neurodevelopmental outcome was done at three years of age by assessment of the Bayley Scales of Infant Development II (BSID-II) During the study period from January 1st 2000, and December 31st 2002 a total of 284 preterm infants less than 30 weeks´ gestational age were admitted to the neonatal intensive care unit of the Medical University of Vienna. Neurodevelopmental outcome could be obtained in 148/284 infants at the age of three years and these infants therefore fulfilled the inclusion criteria for this study'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '29 Weeks', 'minimumAge': '23 Weeks', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'inclusion of all preterm infants born below 30 weeks gestational age within the study period at medical university vienna', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* gestational age \\< 30 weeks\n\nExclusion Criteria:\n\n* brain malformation\n* inborn error of metabolism'}, 'identificationModule': {'nctId': 'NCT00728234', 'briefTitle': 'Analysis of Correlation of Amplitude-Integrated EEG and Neurodevelopmental Outcome in Preterm Infants', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Analysis of Amplitude-Integrated Electroencephalography and Its Predictive Value for Neurodevelopmental Outcome in Preterm Infants Born Below 30 Weeks Gestational Age', 'orgStudyIdInfo': {'id': 'Klebermass_01'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'all infants born below 30 weeks gestational age at the medical university vienna within the study period (01/2000 - 12/2002)', 'interventionNames': ['Device: aEEG recording']}], 'interventions': [{'name': 'aEEG recording', 'type': 'DEVICE', 'otherNames': ['1 - all infants < 30 weeks gestational age'], 'description': 'weekly recordings with aEEG', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Medical University', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'overallOfficials': [{'name': 'Arnold Pollak, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Medical University Vienna, Head of Department of Pediatrics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr.Katrin Klebermass, Univ.Prof.Dr.Manfred Weninger', 'oldOrganization': 'Medical University Vienna, Department of Pediatrics'}}}}