Ignite Creation Date:
2025-12-24 @ 2:02 PM
Ignite Modification Date:
2026-02-25 @ 8:53 PM
Study NCT ID:
NCT00544895
Status:
COMPLETED
Last Update Posted:
2011-06-23
First Post:
2007-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neonatal Estimation Of Brain Damage Risk And Identification of Neuroprotectants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001925', 'term': 'Brain Damage, Chronic'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'whole blood, urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-22', 'studyFirstSubmitDate': '2007-10-12', 'studyFirstSubmitQcDate': '2007-10-15', 'lastUpdatePostDateStruct': {'date': '2011-06-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-10-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Brain white matter damage (WMD, defined by MRI ,US, EEG)', 'timeFrame': 'during stay in NICU and until discharge'}], 'secondaryOutcomes': [{'measure': 'Developmental assessment', 'timeFrame': 'at 2 years of age'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Brain Damage, Chronic']}, 'referencesModule': {'references': [{'pmid': '17992017', 'type': 'BACKGROUND', 'citation': 'Dammann O, Cesario A, Hallen M. NEOBRAIN--an EU-funded project committed to protect the newborn brain. Neonatology. 2007;92(4):217-8. doi: 10.1159/000102967. Epub 2007 May 21. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'NEOBRAIN brings together small and medium sized enterprises (SMEs), industry and academic groups devoted to the diagnosis, management, and neuroprotection in newborns with perinatal brain damage. The focus of NEOBRAIN is to identify strategies prevention of brain damage mainly observed in preterm newborns. (Copy from www.neobrain.eu)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Preterm newborns with a gestational age \\< 28wks', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Gestational age \\< 28 weeks'}, 'identificationModule': {'nctId': 'NCT00544895', 'acronym': 'NEOBRAIN', 'briefTitle': 'Neonatal Estimation Of Brain Damage Risk And Identification of Neuroprotectants', 'organization': {'class': 'OTHER', 'fullName': 'Hannover Medical School'}, 'officialTitle': 'Neonatal Estimation Of Brain Damage Risk And Identification of Neuroprotectants', 'orgStudyIdInfo': {'id': 'LSHM-CT-2006-036534'}}, 'contactsLocationsModule': {'locations': [{'zip': '6020', 'city': 'Innsbruck', 'country': 'Austria', 'facility': 'Medizinische Universität Innsbruck', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'zip': 'F-75019', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Robert Debré', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '13353', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité, Campus Virchow Klinikum', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '45122', 'city': 'Essen', 'country': 'Germany', 'facility': 'Universität Duisburg-Essen', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '30625', 'city': 'Hanover', 'country': 'Germany', 'facility': 'Hannover Medical School', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'city': 'Milan', 'country': 'Italy', 'facility': 'Fondazione I.R.C.C.S Ospedale Maggiore Policlinico MA.RE.', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '53100', 'city': 'Siena', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Universitaria Senese', 'geoPoint': {'lat': 43.31822, 'lon': 11.33064}}, {'zip': '3508 AB', 'city': 'Utrecht', 'country': 'Netherlands', 'facility': "Wilhelmina Children's Hospital", 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}, {'zip': '41685', 'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Perinatal Center', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'zip': '22185', 'city': 'Lund', 'country': 'Sweden', 'facility': 'University Hospital', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}, {'zip': '75185', 'city': 'Uppsala', 'country': 'Sweden', 'facility': "Academic Children's Hospital", 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}, {'zip': '1211', 'city': 'Geneva', 'country': 'Switzerland', 'facility': 'Hôpital des Enfants', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}], 'overallOfficials': [{'name': 'Olaf Dammann', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Medical School Hannover'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hannover Medical School', 'class': 'OTHER'}, 'collaborators': [{'name': 'European Commission', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Prof. Dr. med. Olaf Dammann', 'oldOrganization': 'Perinatal Infectious Disease Epidemiology Unit - Medical School Hannover'}}}}