Neonatal MeningitisNEO-MENINGITISNCT04009551
Epidemiology, Treatment and Prognosis of Neonatal Meningitis in Turkey: A Multicenter Study
An observational study of Neonatal Meningitis, run by Zekai Tahir Burak Women's Health Research and Education Hospital at 5 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 30 days
- Conditions the study is for
- Neonatal Meningitis
- How many people
- 500 participants
- Where
- 5 sitesTurkey (Türkiye)
- Study dates
- 1 Jun 2019to 1 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 30 days
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
Who cannot join
- Major congenital anomalies
- Cultures positive for coagulase-negative staphylococci (CONS) were excluded as possible contaminants, if not clinically and laboratory compatible with meningitis.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Turkey (Türkiye)5 sites, 5 recruiting
- Recruiting
Zekai Tahir Burak Women's Health Research and Education Hospital
Ankara
Fuat Emre Canpolat, M.D., +903123065000, femrecan@gmail.com
- Recruiting
Bursa Yuksek Ihtisas Research and Education Hospital
Bursa
Mehmet Nevzat Cizmeci, M.D., +902242955000, nevzatcizmeci@gmail.com
- Recruiting
Gazi Yasargil Education Research Hospital
Diyarbakır
Nilufer Okur, M.D., +904122519129, n.matur@hotmail.com
- Recruiting
İstanbul Kanuni Sultan Süleyman Training and Research Hospital
Istanbul
Merih Cetinkaya, M.D., +902124041500, drmerih@yahoo.com
- Recruiting
Izmir Katip Celebi University, Medical Faculty
Izmir, 35590
Mehmet Yekta Oncel, MD, +902323394581, dryekta@gmail.com
About this study
Official title: 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.
- Conditions
- Neonatal Meningitis
- Keywords
- meningitis, epidemiology, neonate, newborn
- Medical subject headings
- Meningitis
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: average of 5 years
Secondary outcomes (3)
Causative organisms
Number and types of isolated microorganisms in CSF cultures
Measured: average of 5 years
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.
Measured: 18 to 24 months
Mortality
Neonatal meningitis related mortality
Measured: up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start1 Jun 2019
- Primary completion1 Oct 2019 (estimated)
- Study completion1 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal MeningitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Yekta Oncel, Tepecik Training and Research Hospital
- Investigators
- Mehmet Yekta Oncel, M.D., Principal investigator, Tepecik Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04009551
- Sponsor's protocol ID
- Tepecik35
- Acronym
- NEO-MENINGITIS
- Status last verified
- Jul 2019
- First submitted
- 2 Jul 2019
- Last updated
- 9 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zekai Tahir Burak Women's Health Research and Education Hospital
- ClinicalTrials.gov ID
- NCT04009551
- Acronym / sponsor ID
- NEO-MENINGITIS / Tepecik35
- Conditions
- Neonatal Meningitis
- Keywords
- meningitis, epidemiology, neonate, newborn
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Zekai Tahir Burak Women's Health Research and Education HospitalUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Oct 2019 (estimated)
- Study completion
- 1 Oct 2019 (estimated)
- First posted
- 5 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 30 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Major congenital anomalies
- Cultures positive for coagulase-negative staphylococci (CONS) were excluded as possible contaminants, if not clinically and laboratory compatible with meningitis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
3 secondary outcomes
Causative organisms
Time frame: average of 5 years
Neurodevelopmental Outcome
Time frame: 18 to 24 months
Mortality
Time frame: up to 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Neonatal Meningitis
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Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
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A Follow-up Trial of GBS-NN/NN2 Vaccine in Healthy Pregnant Women
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National Bacterial Meningitis Study in Children and Newborns
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Not yet recruiting
Neonatal Comfort Seat Allowing Safe Lumbar Puncture and Minimizing Failure: a Randomized Controlled Trial
Sepsis, Meningitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehmet Yekta Oncel, M.D. principal investigator
Tepecik Training and Research Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Meningitis, run by Zekai Tahir Burak Women's Health Research and Education Hospital at 5 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mehmet Yekta Oncel, M.D. (+902323394581, dryekta@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of neonatal meningitis (time frame: average of 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2019.