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出境医 / 临床实验 / Epidemiology, Treatment and Prognosis of Neonatal Meningitis in Turkey: A Multicenter Study (NEO-MENINGITIS)

Epidemiology, Treatment and Prognosis of Neonatal Meningitis in Turkey: A Multicenter Study (NEO-MENINGITIS)

Study Description
Brief Summary:

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.


Condition or disease
Neonatal Meningitis

Study Design
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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Zekai Tahir Burak Women's Health Research and Education Hospital
Actual Study Start Date : June 1, 2019
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : October 1, 2019
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. Incidence of neonatal meningitis [ Time Frame: average of 5 years ]
    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)


Secondary Outcome Measures :
  1. Causative organisms [ Time Frame: average of 5 years ]
    Number and types of isolated microorganisms in CSF cultures

  2. Neurodevelopmental Outcome [ Time Frame: 18 to 24 months ]
    - 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.

  3. Mortality [ Time Frame: up to 28 days ]
    Neonatal meningitis related mortality


Eligibility Criteria
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Ages Eligible for Study:   up to 30 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

In this study,

  1. Lumbar puncture performed due to suspected meningitis and
  2. CSF laboratory findings are consistent with meningitis and
  3. Positivity in CSF culture and/or CSF PCR
  4. 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.
Criteria

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.
Contacts and Locations

Contacts
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Contact: Mehmet Yekta Oncel, M.D. +902323394581 dryekta@gmail.com
Contact: Eda Karadag Oncel, M.D. +902324696969 dredakaradag@gmail.com

Locations
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Turkey
Zekai Tahir Burak Women's Health Research and Education Hospital Recruiting
Ankara, Turkey
Contact: Fuat Emre Canpolat, M.D.    +903123065000    femrecan@gmail.com   
Bursa Yuksek Ihtisas Research and Education Hospital Recruiting
Bursa, Turkey
Contact: Mehmet Nevzat Cizmeci, M.D.    +902242955000    nevzatcizmeci@gmail.com   
Gazi Yasargil Education Research Hospital Recruiting
Diyarbakır, Turkey
Contact: Nilufer Okur, M.D.    +904122519129    n.matur@hotmail.com   
İstanbul Kanuni Sultan Süleyman Training and Research Hospital Recruiting
İstanbul, Turkey
Contact: Merih Cetinkaya, M.D.    +902124041500    drmerih@yahoo.com   
Izmir Katip Celebi University, Medical Faculty Recruiting
İzmir, Turkey, 35590
Contact: Mehmet Yekta Oncel, MD    +902323394581    dryekta@gmail.com   
Sponsors and Collaborators
Zekai Tahir Burak Women's Health Research and Education Hospital
Investigators
Layout table for investigator information
Principal Investigator: Mehmet Yekta Oncel, M.D. Tepecik Training and Research Hospital
Tracking Information
First Submitted Date July 2, 2019
First Posted Date July 5, 2019
Last Update Posted Date July 9, 2019
Actual Study Start Date June 1, 2019
Estimated Primary Completion Date October 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 3, 2019)
Incidence of neonatal meningitis [ Time Frame: average of 5 years ]
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)
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 6, 2019)
  • Causative organisms [ Time Frame: average of 5 years ]
    Number and types of isolated microorganisms in CSF cultures
  • Neurodevelopmental Outcome [ Time Frame: 18 to 24 months ]
    - 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.
  • Mortality [ Time Frame: up to 28 days ]
    Neonatal meningitis related mortality
Original Secondary Outcome Measures
 (submitted: July 3, 2019)
  • Causative organisms [ Time Frame: average of 5 years ]
    Number and types of isolated microorganisms in CSF cultures
  • Neurodevelopmental Outcome [ Time Frame: 18 to 24 months ]
    Bayley Scales of Infant Development, Second Edition (BSID II or III), was performed a comprehensive assessment including neurological and developmental evaluation.
  • Mortality [ Time Frame: up to 28 days ]
    Neonatal meningitis related mortality
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Epidemiology, Treatment and Prognosis of Neonatal Meningitis in Turkey: A Multicenter Study
Official Title Zekai Tahir Burak Women's Health Research and Education Hospital
Brief Summary

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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population

In this study,

  1. Lumbar puncture performed due to suspected meningitis and
  2. CSF laboratory findings are consistent with meningitis and
  3. Positivity in CSF culture and/or CSF PCR
  4. 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.
Condition Neonatal Meningitis
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 3, 2019)
500
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 1, 2019
Estimated Primary Completion Date October 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages up to 30 Days   (Child)
Accepts Healthy Volunteers No
Contacts
Contact: Mehmet Yekta Oncel, M.D. +902323394581 dryekta@gmail.com
Contact: Eda Karadag Oncel, M.D. +902324696969 dredakaradag@gmail.com
Listed Location Countries Turkey
Removed Location Countries  
 
Administrative Information
NCT Number NCT04009551
Other Study ID Numbers Tepecik35
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Mehmet Yekta Oncel, Tepecik Training and Research Hospital
Study Sponsor Zekai Tahir Burak Women's Health Research and Education Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Mehmet Yekta Oncel, M.D. Tepecik Training and Research Hospital
PRS Account Zekai Tahir Burak Women's Health Research and Education Hospital
Verification Date July 2019