Clinicians
Background
Babies with bacterial meningitis are treated with antibiotics in the UK. In older children with meningitis, giving steroids together with antibiotics can reduce serious long-term problems. The BOBBi trial aims to find out if giving a steroid called Dexamethasone to babies under 3 months old with suspected bacterial meningitis improves outcomes and reduces long term difficulties.
Trial Design
BOBBi is a multisite, open-label, two-arm, parallel-group, pragmatic, randomised controlled trial with an integrated health economic evaluation and an internal pilot.
The trial aims to evaluate whether administering dexamethasone, compared to not administering dexamethasone, as an adjunct to treatment-as-usual based on National Institute for Health and Care Excellence (NICE) guidelines in babies less than 3 months of age with suspected or confirmed bacterial meningitis, is clinically and cost-effective.
Babies will be put into one of two groups:
- Dexamethasone, in addition to treatment-as-usual based on NICE guidelines
- Treatment-as-usual based on NICE guidelines (No Dexamethasone)
We will compare the two groups to find out whether giving steroids or not affects babies' health in the short term. Babies will also be followed up until they are 2 years old to understand if there are any differences in their long term development.
The trial will recruit 965 infants in approximately 60 hospitals in the UK over a 4.5 year recruitment period.
Call for recruiting sites!
BOBBi is due to start recruitment in June 2026 and we are currently looking for recruiting sites to take part. We expect babies to be recruited from NHS neonatal units, paediatric emergency departments, paediatric assessment units, paediatric intensive care units and paediatric wards. If your site is interested in taking part, please fill in this short expression of interest form and then a member of the team will contact you.
https://forms.office.com/e/1hdjtLx8nR
If you have any questions, you can contact the BOBBI study team by emailing bobbi@npeu.ox.ac.uk