- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04009551
Epidemiology, Treatment and Prognosis of Neonatal Meningitis in Turkey: A Multicenter Study (NEO-MENINGITIS)
Zekai Tahir Burak Women's Health Research and Education Hospital
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.
The 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.
연구 개요
상태
정황
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
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Ankara, 칠면조
- 모병
- Zekai Tahir Burak Women's Health Research and Education Hospital
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연락하다:
- Fuat Emre Canpolat, M.D.
- 전화번호: +903123065000
- 이메일: femrecan@gmail.com
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Bursa, 칠면조
- 모병
- Bursa Yuksek Ihtisas Research and Education Hospital
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연락하다:
- Mehmet Nevzat Cizmeci, M.D.
- 전화번호: +902242955000
- 이메일: nevzatcizmeci@gmail.com
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Diyarbakır, 칠면조
- 모병
- Gazi Yasargil Education Research Hospital
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연락하다:
- Nilufer Okur, M.D.
- 전화번호: +904122519129
- 이메일: n.matur@hotmail.com
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İstanbul, 칠면조
- 모병
- Istanbul Kanuni Sultan Süleyman Training and Research Hospital
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연락하다:
- Merih Cetinkaya, M.D.
- 전화번호: +902124041500
- 이메일: drmerih@yahoo.com
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İzmir, 칠면조, 35590
- 모병
- Izmir Katip Celebi University, Medical Faculty
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연락하다:
- Mehmet Yekta Oncel, MD
- 전화번호: +902323394581
- 이메일: dryekta@gmail.com
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
In this study,
- Lumbar puncture performed due to suspected meningitis and
- CSF laboratory findings are consistent with meningitis and
- Positivity in CSF culture and/or CSF PCR
Neonates hospitalized between 1 January 2014 and 31 May 2019 will be included in the study.
- 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.
- Term infants will be included in the study until 1 month and preterm infants will be adjusted until the first month.
설명
Inclusion Criteria:
- Subject has a positive cerebrospinal fluid culture/PCR of bacterial pathogen.
- Subject has a positive blood culture of bacterial pathogen and counts of white blood cells in cerebrospinal fluid ≥20 /mm3.
Exclusion Criteria:
- Major congenital anomalies
- Cultures positive for coagulase-negative staphylococci (CONS) were excluded as possible contaminants, if not clinically and laboratory compatible with meningitis.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Incidence of neonatal meningitis
기간: average of 5 years
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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)
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average of 5 years
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Causative organisms
기간: average of 5 years
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Number and types of isolated microorganisms in CSF cultures
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average of 5 years
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Neurodevelopmental Outcome
기간: 18 to 24 months
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- 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.
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18 to 24 months
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Mortality
기간: up to 28 days
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Neonatal meningitis related mortality
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up to 28 days
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공동 작업자 및 조사자
수사관
- 수석 연구원: Mehmet Yekta Oncel, M.D., Tepecik Training and Research Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .