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. 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 from 32+0 corrected gestational weeks+days (at randomisation) up to and including 3 months’ corrected age Suspected or confirmed bacterial meningitis based on having one or more of the following three clinical and/or laboratory features Seizures or bulging fontanelle or altered consciousness (coma) where bacterial meningitis is suspected Suspected bacterial meningitis based on having one or more of the following three clinical and/or laboratory features: raised cerebrospinal fluid (CSF) white cell count (>20/mm3 for neonates ≤28 days post birth; >5/mm3 for babies > 28 days post birth) CSF protein ≥0.8g/L CSF/blood glucose ratio <0.5 Positive CSF Gram stain OR positive CSF polymerase chain reaction (PCR) OR culture for a relevant bacterium Exclusion criteria First dose of antibiotic for suspected/confirmed meningitis administered more than 12 hours prior to planned administration of dexamethasone Preterm baby less than 34 gestational weeks at birth who is within the first 7 days after birth Previous neurosurgical intervention or shunt Major congenital anomaly Known hypersensitivity to dexamethasone or any of its excipients Previous randomisation into this trial No realistic chance of survival 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 share as much information as you can for now, don't worry if some sections are missing, this can be provided later by emailing bobbi@npeu.ox.ac.uk 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? Please note if this target is not feasible for your site, you will still be considered. 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 your microbiology laboratory on site or elsewhere? On-site Elsewhere If elsewhere, please clarify: Do you routinely perform PCR on CSF samples? PCR = Polymerase chain reaction CSF = Cerebrospinal fluid Yes No If yes, which test do you use? If yes, how long does it typically take for CSF sample results to be available? If possible, please estimate the number of CSF samples from babies <3 months' of corrected age routinely processed by your lab? You can provide by month or by year Monthly: Annually: Do you routinely follow the NICE neonatal infection and NICE meningitis guidelines with regard to management of bacterial meningitis, including empiric antibiotic choice? Yes No If no, do you follow a local guideline? Please provide a link or upload a copy. You can upload here: Please upload at most one file Upload file Title Comment File name Upload file 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 Please specify your network of hospitals you routinely transfer babies out to (continuing care sites) Please list all sites: Site 1 Site 2 Site 3 Site 4 Site 5 Site 6 Add line Apart from English, what are the top three spoken languages at your site? 1 2 3 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?
