Survey options Load unfinished survey Resume later default Caution: JavaScript execution is disabled in your browser or for this website. You may not be able to answer all questions in this survey. Please, verify your browser parameters. BOBBi Site Feasibility Questionnaire Please review the trial summary and complete the questionnaire about the feasibility of running BOBBi at your site. Please do not worry if you cannot fill out all the details now. To add information to your form after submission, please email additional details to bobbi@npeu.ox.ac.uk. Study name Better Outcomes in Babies with Bacterial meningitis, a randomised controlled trial: BOBBi Study (short) title BOBBi Sponsor City St George's University of London Clinical Trials Unit National Perinatal Epidemiology Unit CTU Population Babies from 32+0 corrected gestational weeks+days up to and including 3 months’ corrected age at randomisation, with suspected bacterial meningitis. Intervention Steroid (dexamethasone) to treat suspected bacterial meningitis, in addition to treatment-as-usual based on NICE guidelines Comparator Treatment-as-usual based on NICE guidelines (No Dexamethasone) Outcomes Survival without moderate or severe neurodevelopmental impairment at 24 months of age corrected for prematurity Inclusion Criteria Babies must fulfil one of the following age-based criteria: Babies born at >= 37+0 gestational weeks: Up to and including 90 days from their birth date OR Babies born at 34+0 to 36+6 gestational weeks: Up to and including 90 days corrected age OR Babies born less than 34+0 gestational weeks: Are between 32+0 corrected gestational weeks+days and 90 days corrected age AND are older than 7 days of age Planned or initiated treatment with antibiotics for suspected or confirmed bacterial meningitis based on having one or more of the following three clinical and/or laboratory features: 1. Seizures or bulging fontanelle or altered consciousness (coma) 2. Blood C-Reactive Protein (CRP) ≥20 mg/L* AND one or more of: a. raised cerebrospinal fluid (CSF) white cell count (>20/mm3 for neonates ≤28 days post birth; >5/mm3 for babies >28 days post birth)** b. CSF protein ≥0.8 g/L** c. CSF/blood glucose ratio <0.5 3. Positive CSF Gram stain OR positive CSF polymerase chain reaction (PCR) for a relevant bacterium OR CSF culture for a relevant bacterium. *If CRP is not available then an abnormal procalcitonin (PCT) threshold may be used instead (i.e. ≥0.5 mg/dL). **When interpreting the results of cerebrospinal fluid (CSF) investigations, take into account red cells in the sample, which may suggest blood contamination or a different diagnosis. In the case of blood contamination. If the CSF RBC count is >=1000 then CSF WBC and CSF protein should be adjusted- subtract 1 WBC per 500 RBCs- subtract 0.01 g/l protein per 1000 RBCs Exclusion criteria Where the randomisation cannot occur within 12 hours of the first administration of antibiotics for meningitis, or within 12 hours of the first administration of changed dose/type of antibiotics where antibiotics have been changed in dose or type for newly suspected or confirmed meningitis Previous neurosurgical intervention or shunt Known hypersensitivity to dexamethasone or any of its excipients Previous randomisation into this trial Consent model A deferred consent model will be used. Babies with a diagnosis of suspected bacterial meningitis will be randomised when they meet the above criteria. Informed consent will subsequently be sought for ongoing trial participation and data collection. Recruitment Babies will be recruited from neonatal units (NNU), paediatric emergency departments (PED), paediatric assessment units (PAU), paediatric intensive care units (PICU) and paediatric wards (PW). It is expected that each site will include 2 or more units (e.g. NNU and PW) Planned recruitment start date & length 4.5 year recruitment period, planned start date 01 June 2026 Sample size 965 Proposed number of sites 60, with recruitment across 2 or more departments If you have any questions, please email bobbi@npeu.ox.ac.uk Site-specific Information Please complete as much information as you can but do not worry if you cannot fill out all the details now, additional details can be emailed to bobbi@npeu.ox.ac.uk after submission. Name of NHS Trust Name of Hospital Principal Investigator details: We are aiming for two or more departments at your site to be open to recruitment. We anticipate there will be an overall Principal Investigator (PI) for the NHS Trust with Co-PIs for each department/unit. A Co-PI does not necessarily need to be a medically trained doctor, please contact us if you have any queries. Name of proposed overall Principal Investigator Qualifications of Principal Investigator Email Address Does the PI have up-to-date GCP training?GCP training should be completed every 2-3 years Which department is the PI based in? Please choose... Neonatal Unit Paediatric Emergency Department Paediatric Assessment Unit Paediatric Intensive Care Unit Paediatric Ward How many of the following beds/cots do you have at your hospital? Only integer values may be entered in these fields. Neonatal cots Paediatric beds PICU beds How many babies aged from 32+0 corrected gestational weeks+days up to and including 3 months' corrected age with proven bacterial meningitis do you care for annually? You can provide overall or by department Overall: per year By department: per year Has this trial been discussed with your colleagues and is there a unit willingness to participate in the trial? Yes No Not discussed Neonatal Unit Yes No Not discussed Paediatric Emergency Department Yes No Not discussed Paediatric Assessment Unit Yes No Not discussed Paediatric Intensive Care Unit Yes No Not discussed Paediatric Ward Yes No Not discussed Would an annual target of around 4-5 babies be feasible for your NHS trust? If this target is not feasible, please estimate how many babies your site may be able to recruit in the comment box. Yes No Please enter your comment here: Do you or your colleagues (doctors/nurses) envisage any major barriers to recruiting to this trial? Yes No If yes, please provide further information Do you routinely follow up infants with bacterial meningitis at your hospital? Yes No If yes, please provide further information (hospital, clinic, age for recall, assessment measures): Is there existing dedicated research infrastructure at your site? i.e. nurse or midwife funding/RDN funding The study will provide full training and support to sites. The study will provide funding for NHS research activity at sites and will be adopted on the NIHR portfolio to receive funding via accruals. Yes No If yes, please provide further information If possible, please list any other key contacts: Please include details (names & email addresses) for Co-PIs, research nurses and other key contacts for each department participating. If you enter other key contact, please state their role. Neonatal Unit Paediatric Assessment Unit Paediatric Intensive Care Unit Paediatric Ward Co-Principal Investigator(s) Neonatal Unit Paediatric Assessment Unit Paediatric Intensive Care Unit Paediatric Ward Lead Research Nurse(s) Neonatal Unit Paediatric Assessment Unit Paediatric Intensive Care Unit Paediatric Ward Other key contact(s) e.g. R&D Neonatal Unit Paediatric Assessment Unit Paediatric Intensive Care Unit Paediatric Ward Is there anything else that you would like to tell us? Name and email address of person completing this form: Submit Load unfinished survey Resume later Exit and clear survey Exit and clear survey Please confirm you want to clear your response?
