Bacterial MeningitisNCT03499652
Neonatal Bacterial Meningitis Cohort
An observational study of Bacterial Meningitis and Neonatal Infection, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 2 sites in China.
Trial summary
Neonatal bacterial meningitis (BM) is a devastating infection that occurs more commonly in neonates than in any other age group, and is associated with significant morbidity and mortality, especially in developing countries. Read more about this study
- Who is it for?
- Ages 1 day to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Bacterial Meningitis, Neonatal Infection
- What is being tested?
- neonatal bacterial meningitis risk score
- How many people
- 10,000 participants
- Where
- 2 sitesChina
- Study dates
- 1 Dec 2017to 31 Dec 2023
- How long will I take part?
- 2 Years
- 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 1 day to 28 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: Eligible participants were full-term neonates, aged older than 3 days, who were suspected with BM and received LPs.
Who may be able to join
- Subject has a positive cerebrospinal fluid culture of bacterial pathogen(s)
- Subject has a positive blood culture of bacterial pathogen and counts of white blood cells in cerebrospinal fluid ≥ 20×106/L
- Subject has counts of white blood cells in cerebrospinal fluid ≥ 20×106/L and counts of neutrophils ≥ 10×106/L as well as suspected clinical symptoms
Who cannot join
- History of brain trauma, brain tumor, cerebral palsy, epilepsy, and ventricular shunt device
- History of accepting neurosurgery
- Subject has missing data
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200092
Yongjun Zhang, doctor
- Recruiting
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, 200092
Yongjun Zhang, doctor
About this study
Official title: A Multicenter Prospective Cohort Study on Neonatal Bacterial Meningitis
Neonatal bacterial meningitis (BM) is a devastating infection that occurs more commonly in neonates than in any other age group, and is associated with significant morbidity and mortality, especially in developing countries. In this study, we aimed to develop a clinical risk score model, according to the available clinical syndromes and commonly laboratory tests, for screening BM among full-term neonates in a large-scale retrospective cohort, and prospectively validated the risk score in multicenter cohort.
Read the detailed description
In this study, we aimed to develop a clinical risk score model, according to the available clinical syndromes and commonly laboratory tests, for screening BM among full-term neonates in a large-scale retrospective cohort, and prospectively validated the risk score in multicenter cohort.
- Conditions
- Bacterial Meningitis, Neonatal Infection
- Being tested
- neonatal bacterial meningitis risk score
- Medical subject headings
- Meningitis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neonatal bacterial meningitis risk scoreDiagnostic test
In the validation cohort,according to the neonatal bacterial meningitis risk score, we will suggest neonates who reach certain score to take a lumbar puncture, but we will not interfere with clinicians' decision
| Study group | Role | What they receive |
|---|---|---|
| derivation cohort | The data of derivation cohort are used to derive the neonatal bacterial meningitis risk score Receives: Diagnostic Test: neonatal bacterial meningitis risk score | |
| validation cohort | The data of validation cohort are used to validate the neonatal bacterial meningitis risk score Receives: Diagnostic Test: neonatal bacterial meningitis risk score |
What is being measured
The primary outcome is the main question the study is designed to answer.
neonatal bacterial meningitis risk score
Our researchers grade the patients with the neonatal bacterial meningitis risk score to identify patients with bacterial meningitis, patients with risk score ≤ 3 points considered to be the low-risk group, and patients with risk score > 3.1 points considered the high-risk group, and the risk score model has no maximum or minimum value.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2018
- Study start1 Dec 2017
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial 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
- Other
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Children's Medical Center, Children's Hospital of Fudan University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03499652
- Sponsor's protocol ID
- XH-17-017
- Status last verified
- Apr 2018
- First submitted
- 8 Apr 2018
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: we plan to share all the individual participant data information available to our cooperative hospitals through emails
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Prospective Cohort Study on Neonatal Bacterial Meningitis
- ClinicalTrials.gov ID
- NCT03499652
- Acronym / sponsor ID
- XH-17-017
- Conditions
- Bacterial Meningitis, Neonatal Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- Shanghai Children's Medical Center, Children's Hospital of Fudan University
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 17 Apr 2018 (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.
Neonatal bacterial meningitis (BM) is a devastating infection that occurs more commonly in neonates than in any other age group, and is associated with significant morbidity and mortality, especially in developing countries. In this study, we aimed to develop a clinical risk score model, according to the available clinical syndromes and commonly laboratory tests, for screening BM among full-term neonates in a large-scale retrospective cohort, and prospectively validated the risk score in multicenter cohort.
Detailed description
In this study, we aimed to develop a clinical risk score model, according to the available clinical syndromes and commonly laboratory tests, for screening BM among full-term neonates in a large-scale retrospective cohort, and prospectively validated the risk score in multicenter cohort.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| derivation cohort | – | Diagnostic Test: neonatal bacterial meningitis risk scoreThe data of derivation cohort are used to derive the neonatal bacterial meningitis risk score |
| validation cohort | – | Diagnostic Test: neonatal bacterial meningitis risk scoreThe data of validation cohort are used to validate the neonatal bacterial meningitis risk score |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Eligible participants were full-term neonates, aged older than 3 days, who were suspected with BM and received LPs.
Key inclusion criteria (3 listed)
- Subject has a positive cerebrospinal fluid culture of bacterial pathogen(s)
- Subject has a positive blood culture of bacterial pathogen and counts of white blood cells in cerebrospinal fluid ≥ 20×106/L
- Subject has counts of white blood cells in cerebrospinal fluid ≥ 20×106/L and counts of neutrophils ≥ 10×106/L as well as suspected clinical symptoms
Key exclusion criteria (3 listed)
- History of brain trauma, brain tumor, cerebral palsy, epilepsy, and ventricular shunt device
- History of accepting neurosurgery
- Subject has missing data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neonatal bacterial meningitis risk scoreIn the validation cohort,according to the neonatal bacterial meningitis risk score, we will suggest neonates who reach certain score to take a lumbar puncture, but we will not interfere with clinicians' decision | Diagnostic test | derivation cohort, validation cohort |
Primary outcome
neonatal bacterial meningitis risk score
Time frame: 1 day
Our researchers grade the patients with the neonatal bacterial meningitis risk score to identify patients with bacterial meningitis, patients with risk score ≤ 3 points considered to be the low-risk group, and patients with risk score > 3.1 points considered the high-risk group, and the risk score model has no maximum or minimum value.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2018.
- Individual participant dataSharing planned: Undecided. we plan to share all the individual participant data information available to our cooperative hospitals through emails
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bacterial Meningitis and Neonatal Infection, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 2 sites in China.
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 3 inclusion and 3 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 17 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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 Yongjun Zhang, doctor (+8602125078310, zhangyongjun@stju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
neonatal bacterial meningitis risk score (time frame: 1 day). 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 17 Apr 2018.