Frequently Asked Questions
Recruitment
Are there any documents available for review before we commit to being a recruiting site?
We are preparing for regulatory approvals and will let you know as soon as documents are available for review. In the meantime, we are inviting prospective sites to complete the Site Feasibility Questionnaire with as much information as possible. Please do not worry if you cannot complete all sections are this time, you can always add any extra details by emailing the BOBBi study team (bobbi@npeu.ox.ac.uk).
When will recruitment start?
Recruitment is due to begin in June 2026, we will contact prospective sites in April/May to discuss site set up.
As a neonatal unit, we only see 1-2 babies a year with meningitis, so can we still take part?
Yes, we know that proven bacterial meningitis is a rare occurrence, so we need lots of hospitals recruiting this small number of babies. There will be more cases of suspected bacterial meningitis that can be recruited, however. As long as another department in your hospital can take part (e.g. paediatrics, PICU or ED) then we would be very happy to welcome you onto the trial.
Eligibility and Randomisation
Should babies be randomised into the trial if they are having seizures, regardless of other meningitis markers?
Babies with seizures should only be randomised onto the trial if healthcare professionals have a “strong suspicion” of meningitis.
Can extremely preterm babies (<32 weeks at birth) be included?
Yes, babies born at any gestational age are eligible as long as they are more that 32+0 corrected gestational weeks, and more than a week old, at the point of enrolment.
Why does BOBBi use “suspected” and not “strongly suspected”, like the NICE Guidance?
A baby who comes in with “suspected” meningitis will likely be treated as if they have meningitis - until proven otherwise. Therefore, they are eligible for inclusion.
Is a baby still eligible even if the CSF same does not come back positive for bacterial meningitis?
Yes, any baby with suspected meningitis is eligible if they meet the required inclusion/exclusion criteria. If a viral pathogen is confirmed as the sole cause of meningitis while the patient is still on dexamethasone then the IV dexamethasone can be stopped. The dexamethasone can also be stopped if the IV antibiotics are stopped for any reason.
If the CSF becomes contaminated with blood during the lumbar puncture, should the sites take this into account when reviewing the sample?
Yes, in the case of blood contamination (more than 1,000 red blood cells), adjust the white cell count (WBC) according to the formula: subtract 1 white blood cell per 500 red blood cells; and subtract 0.01g/l protein per 1000 red blood cells.
Can babies be randomised on clinical suspicion and then taken off of Dexamethasone based on confirming/discarding diagnosis on lab results?
This is possible but dexamethasone would only be stopped if a viral cause is confirmed as the sole cause of meningitis and/or if antibiotics are stopped.
If the lumbar puncture results will take more than 12 hours to receive, should the baby be randomised to meet the required window?
Babies with clinical features (seizures/coma/bulging fontanelle) are eligible, and do not require a lumbar puncture to be recruited. Sites should however perform a lumbar puncture as soon as possible, according to good practice.
Consent
Is deferred consent mandatory, or can a site go through consent up-front if achievable?
Sites can approach parents for consent if appropriate, and achievable within the 12-hour window, but the deferred consent model will be used in most cases. This is based upon feedback from parents who have had a baby with meningitis who clearly report that receiving a diagnosis of presumed bacterial meningitis is such a devastating and distressing event that they would be unable to make an informed decision about consent in the first 12 hours following this.
Dexamethasone and Antibiotics
Is there a potential for IV dexamethasone to switch to oral dexamethasone to allow babies to go home?
No, it must be IV, but dexamethasone treatment is only for 4 days.
I don't want to give Dexamethasone to very premature babies, so I don't want to take part.
Because very preterm babies have the worst outcomes from bacterial meningitis, they may also benefit the most from steroids. It is therefore important that we include them. However, we have carefully considered the evidence around the safety of steroids and will only include premature babies once they have reached 32 corrected gestational weeks. Furthermore, for babies who are born at 32 or 33 gestational weeks, they must also be older than 7 days.
Of course, even if you decide not to include very premature babies, you can still participate and recruit only those babies who are less premature.
Does the protocol give specific stop/continue guidance for dexamethasone after the first dose?
If a viral pathogen is confirmed as the sole cause of meningitis while they are still on dexamethasone then the dexamethasone can be stopped. The dexamethasone can also be stopped if the antibiotics are stopped for any other reason
Are site staff required to have completed GCP training to administer dexamethasone?
No, any appropriately qualified and trained study personnel can administer dexamethasone. Additional trial specific IMP training and trial delegation is not required, as this is considered within the remit of their usual clinical roles.
Should a specific type of antibiotic be used?
No, your standard antibiotic for treating meningitis should be used.
Babies may receive 1-2 days of antibiotics before starting dexamethasone, could this affect outcome?
In this scenario (where babies are already on antibiotics), babies are only eligible for randomisation if they can receive dexamethasone within 12 hours of a change of antibiotics (type/dose), where the change has been made because of suspected bacterial meningitis.
Data Collection
Will the CRFs be electronic?
Yes, CRFs will be completed using OpenClinica. Deferred consent will be collected on paper, ideally within 48 hours, or before the baby is discharged or is transferred to another hospital.
Follow Up
How do sites monitor for outcomes up to 8 weeks after randomisation?
After hospital discharge, parents/carers will be contacted at 8 weeks from randomisation to ask if their baby has been re-admitted since discharge. If applicable, details about the hospital re-admission will be collected by the research team from medical notes using trial-specific CRFs.
Will the two year follow up questionnaires be sent out by sites?
No, Parents/carers will be sent the questionnaires by the central trial team (one at 12 months of age corrected for prematurity and another at 24 months of age corrected for prematurity) - both of these will be submitted electronically via email or on paper/over the phone if requested back to the clinical trials unit.
If you have any questions, you can contact the BOBBI study team by emailing bobbi@npeu.ox.ac.uk
