Epidemiology, Treatment and Prognosis of Neonatal Meningitis in Turkey: A Multicenter Study

• Conditions: Neonatal Meningitis

• Registration Number: NCT04009551
• Lead Sponsor: 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 available

Study Timeline

• Study Start: 2019-06-01
• Status Verified: 2019-07
• Study First Submitted: 2019-07-02
• Study First Submitted QC: 2019-07-03
• Study First Posted: 2019-07-05
• Last Update Submitted: 2019-07-06
• Last Update Posted: 2019-07-09
• Primary Completion: 2019-10-01
• Study Completion: 2019-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of neonatal meningitis	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

Name	Time	Method
Causative organisms	average of 5 years	Number and types of isolated microorganisms in CSF cultures
Neurodevelopmental Outcome	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	up to 28 days	Neonatal meningitis related mortality

Trial Locations

Locations (5)

Zekai Tahir Burak Women's Health Research and Education Hospital; 🇹🇷 Ankara, Turkey

Gazi Yasargil Education Research Hospital; 🇹🇷 Diyarbakır, Turkey

İstanbul Kanuni Sultan Süleyman Training and Research Hospital; 🇹🇷 İstanbul, Turkey

Izmir Katip Celebi University, Medical Faculty; 🇹🇷 İzmir, Turkey

Bursa Yuksek Ihtisas Research and Education Hospital; 🇹🇷 Bursa, Turkey