Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2025-12-27 @ 9:34 AM
Study NCT ID:
NCT00516334
Status:
UNKNOWN
Last Update Posted:
2012-07-27
First Post:
2007-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Bedside EEG to Evaluate Brain Injury in Premature Newborns
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D012640', 'term': 'Seizures'}, {'id': 'D002547', 'term': 'Cerebral Palsy'}, {'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001925', 'term': 'Brain Damage, Chronic'}, {'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2013-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-07-26', 'studyFirstSubmitDate': '2007-08-13', 'studyFirstSubmitQcDate': '2007-08-13', 'lastUpdatePostDateStruct': {'date': '2012-07-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-08-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['brain', 'electroencephalography', 'premature infant', 'neurodevelopment'], 'conditions': ['Brain Injury', 'Seizures', 'Cerebral Palsy']}, 'descriptionModule': {'briefSummary': 'This study is evaluating whether a bedside brainwave monitor can be used to detect early brain injury in premature infants.', 'detailedDescription': "Patient enrollment and electroencephalographic (EEG) and clinical data collection stopped May 2009. Data analysis is ongoing, and results have been described (O'Reilly D, Navakatikyan MA, Filip M, Greene D, Van Marter LJ. Peak to Peak Amplitude in Neonatal Brain Monitoring of Premature Infants. Clin Neurophysiol 2012 May 16), via publication in a peer-reviewed journal. Another manuscript has been completed and is undergoing revision for resubmission. We anticipate several additional articles will be completed from the data collected during this study. There is no relationship between industry and no current funding for this study. We maintain institutional review board approval due to ongoing data analysis."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '36 Months', 'minimumAge': '1 Day', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Infants \\<29 weeks gestational age', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infants inborn below 28 weeks gestation\n\nExclusion Criteria:\n\n* At birth, deemed not likely to survive 7 days or more\n* Major intracranial congenital anomaly'}, 'identificationModule': {'nctId': 'NCT00516334', 'acronym': 'BrainZ', 'briefTitle': 'Study of Bedside EEG to Evaluate Brain Injury in Premature Newborns', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'Advanced Electrophysiological Studies of the Premature Newborn Infant Brain: Understanding Brain Injury', 'orgStudyIdInfo': {'id': '2003-P-000088'}}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Linda J Van Marter, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}, {'name': "Deirdre O'Reilly, MD, MPH", 'role': 'STUDY_DIRECTOR', 'affiliation': "Boston Children's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending Neonatologist and Associate Professor of Pediatrics Harvard Medical School', 'investigatorFullName': 'Linda J. Van Marter, M.D., M.P.H.', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}