Neonatal Meningitis Clinical Trial
— NEO-MENINGITISOfficial title:
Zekai Tahir Burak Women's Health Research and Education Hospital
| NCT number | NCT04009551 |
| Other study ID # | Tepecik35 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | June 1, 2019 |
| Est. completion date | October 1, 2019 |
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.
| Status | Recruiting |
| Enrollment | 500 |
| Est. completion date | October 1, 2019 |
| Est. primary completion date | October 1, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A to 30 Days |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Turkey | Zekai Tahir Burak Women's Health Research and Education Hospital | Ankara | |
| Turkey | Bursa Yuksek Ihtisas Research and Education Hospital | Bursa | |
| Turkey | Gazi Yasargil Education Research Hospital | Diyarbakir | |
| Turkey | Istanbul Kanuni Sultan Süleyman Training and Research Hospital | Istanbul | |
| Turkey | Izmir Katip Celebi University, Medical Faculty | Izmir |
| Lead Sponsor | Collaborator |
|---|---|
| Zekai Tahir Burak Women's Health Research and Education Hospital |
Turkey,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence of neonatal meningitis | 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) | average of 5 years | |
| Secondary | Causative organisms | Number and types of isolated microorganisms in CSF cultures | average of 5 years | |
| Secondary | Neurodevelopmental Outcome | - 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. | 18 to 24 months | |
| Secondary | Mortality | Neonatal meningitis related mortality | up to 28 days |
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