Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:30 PM
Study NCT ID:
NCT04009551
Status:
UNKNOWN
Last Update Posted:
2019-07-09
First Post:
2019-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Epidemiology, Treatment and Prognosis of Neonatal Meningitis in Turkey: A Multicenter Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008581', 'term': 'Meningitis'}], 'ancestors': [{'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2019-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-07-06', 'studyFirstSubmitDate': '2019-07-02', 'studyFirstSubmitQcDate': '2019-07-03', 'lastUpdatePostDateStruct': {'date': '2019-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of neonatal meningitis', 'timeFrame': 'average of 5 years', 'description': 'Occurrence of a meningitis in NICU within a specified period of time. (Number of neonatal meningitis cases / Total number of inpatients in the study period)'}], 'secondaryOutcomes': [{'measure': 'Causative organisms', 'timeFrame': 'average of 5 years', 'description': 'Number and types of isolated microorganisms in CSF cultures'}, {'measure': 'Neurodevelopmental Outcome', 'timeFrame': '18 to 24 months', 'description': '\\- Bayley Scales of Infant Development, Second Edition (BSID II), was performed a comprehensive assessment including neurological and developmental evaluation. The mean BSID II score is 100 for Mental Developmental Index (MDI) and Psychomotor Developmental Index (PDI), with a standard deviation (SD) of 15; a score of less than 70 (42 SDs below the mean) indicates a significant delay. Infants who were so severely impaired that testing with the BSID II could not be performed were assigned a MDI and PDI score of 49.'}, {'measure': 'Mortality', 'timeFrame': 'up to 28 days', 'description': 'Neonatal meningitis related mortality'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['meningitis', 'epidemiology', 'neonate', 'newborn'], 'conditions': ['Neonatal Meningitis']}, 'descriptionModule': {'briefSummary': 'Meningitis, defined as inflammation of the meninges caused by different pathogens, is a serious infection associated with high morbidity and mortality. It occurs more commonly in the neonatal period than in any other age group. Neonatal meningitis is a devastating infection that occurs more commonly in neonates than in any other age group, and is associated with significant morbidity and mortality. In this study, we aimed to evaluate epidemiology, treatment and prognosis of neonatal meningitis in a large-scale retrospective multicenter cohort study.\n\nThe main objectives of this study were to assess the incidence, temporal trend, risk factors, causative organisms, and short term outcomes of neonatal meningitis in a large national cohort of newborn infants admitted to Turkey NICUs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '30 Days', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "In this study,\n\n1. Lumbar puncture performed due to suspected meningitis and\n2. CSF laboratory findings are consistent with meningitis and\n3. Positivity in CSF culture and/or CSF PCR\n4. Neonates hospitalized between 1 January 2014 and 31 May 2019 will be included in the study.\n\n * The list of all cases diagnosed as on Neonatal Meningitis with growth in CSF culture and / or causative agent by CSF PCR will be obtained from the hospital's database.\n * Term infants will be included in the study until 1 month and preterm infants will be adjusted until the first month.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject has a positive cerebrospinal fluid culture/PCR of bacterial pathogen.\n* Subject has a positive blood culture of bacterial pathogen and counts of white blood cells in cerebrospinal fluid ≥20 /mm3.\n\nExclusion Criteria:\n\n* Major congenital anomalies\n* Cultures positive for coagulase-negative staphylococci (CONS) were excluded as possible contaminants, if not clinically and laboratory compatible with meningitis.'}, 'identificationModule': {'nctId': 'NCT04009551', 'acronym': 'NEO-MENINGITIS', 'briefTitle': 'Epidemiology, Treatment and Prognosis of Neonatal Meningitis in Turkey: A Multicenter Study', 'organization': {'class': 'OTHER', 'fullName': "Zekai Tahir Burak Women's Health Research and Education Hospital"}, 'officialTitle': "Zekai Tahir Burak Women's Health Research and Education Hospital", 'orgStudyIdInfo': {'id': 'Tepecik35'}}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Fuat Emre Canpolat, M.D.', 'role': 'CONTACT', 'email': 'femrecan@gmail.com', 'phone': '+903123065000'}], 'facility': "Zekai Tahir Burak Women's Health Research and Education Hospital", 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'city': 'Bursa', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Mehmet Nevzat Cizmeci, M.D.', 'role': 'CONTACT', 'email': 'nevzatcizmeci@gmail.com', 'phone': '+902242955000'}], 'facility': 'Bursa Yuksek Ihtisas Research and Education Hospital', 'geoPoint': {'lat': 40.19559, 'lon': 29.06013}}, {'city': 'Diyarbakır', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Nilufer Okur, M.D.', 'role': 'CONTACT', 'email': 'n.matur@hotmail.com', 'phone': '+904122519129'}], 'facility': 'Gazi Yasargil Education Research Hospital', 'geoPoint': {'lat': 37.91363, 'lon': 40.21721}}, {'city': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Merih Cetinkaya, M.D.', 'role': 'CONTACT', 'email': 'drmerih@yahoo.com', 'phone': '+902124041500'}], 'facility': 'İstanbul Kanuni Sultan Süleyman Training and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'zip': '35590', 'city': 'Izmir', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Mehmet Yekta Oncel, MD', 'role': 'CONTACT', 'email': 'dryekta@gmail.com', 'phone': '+902323394581'}], 'facility': 'Izmir Katip Celebi University, Medical Faculty', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}], 'centralContacts': [{'name': 'Mehmet Yekta Oncel, M.D.', 'role': 'CONTACT', 'email': 'dryekta@gmail.com', 'phone': '+902323394581'}, {'name': 'Eda Karadag Oncel, M.D.', 'role': 'CONTACT', 'email': 'dredakaradag@gmail.com', 'phone': '+902324696969'}], 'overallOfficials': [{'name': 'Mehmet Yekta Oncel, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tepecik Training and Research Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Zekai Tahir Burak Women's Health Research and Education Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Neonatology', 'investigatorFullName': 'Mehmet Yekta Oncel', 'investigatorAffiliation': 'Tepecik Training and Research Hospital'}}}}