Clinical trial NCT04009551: Epidemiology, Treatment and Prognosis of Neonatal Meningitis in Turkey: A Multicenter Study
Official title: Zekai Tahir Burak Women's Health Research and Education Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neonatal Meningitis
Keywords: meningitis
epidemiology
neonate
newborn
Lead sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital
Sponsor class: OTHER
First posted: 2019-07-05
Enrollment: 500
Sex: ALL
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: Incidence of neonatal meningitis
timeFrame: average of 5 years
Secondary outcomes:
measure: Causative organisms
timeFrame: average of 5 years
measure: Neurodevelopmental Outcome
timeFrame: 18 to 24 months
measure: Mortality
timeFrame: up to 28 days
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Zekai Tahir Burak Women's Health Research and Education Hospital
city: Bursa
country: Turkey
facility: Bursa Yuksek Ihtisas Research and Education Hospital
city: Diyarbakır
country: Turkey
facility: Gazi Yasargil Education Research Hospital
city: İstanbul
country: Turkey
facility: İstanbul Kanuni Sultan Süleyman Training and Research Hospital
city: İzmir
country: Turkey
facility: Izmir Katip Celebi University, Medical Faculty
Study officials:
affiliation: Tepecik Training and Research Hospital
name: Mehmet Yekta Oncel, M.D.
role: PRINCIPAL_INVESTIGATOR
References: