BOBBi
Research type
Research Study
Full title
Better Outcomes in Babies with Bacterial meningitis (BOBBi) - a multisite, open-label, two-arm, parallel-group, pragmatic, randomised controlled trial to compare dexamethasone versus no dexamethasone as treatment in babies with suspected bacterial meningitis
IRAS ID
1013356
Contact name
Paul Health
Contact email
Sponsor organisation
City St George's, University of London
ISRCTN Number
ISRCTN17216564
Research summary
Aim: To see if giving steroids to babies with suspected bacterial meningitis helps more survive without long-term problems.
Background: Meningitis is an infection around the brain and spinal cord. In babies under 3 months, even with antibiotics about 1 in 20 die and 1 in 3 survivors have lifelong disabilities. In older children, steroids given with antibiotics reduce some harm, but we do not know if this helps young babies.
Study design: We will include babies up to 3 months of age who doctors think have bacterial meningitis. Babies will be randomly allocated to receive the steroid dexamethasone or not, shortly after starting antibiotics. Because bacterial meningitis is an emergency and based on what parents have told us, doctors will start treatment and randomise babies into BOBBi straight away, without first asking the parents. Within about 48 hours we will explain the study to parents and ask if they agree for their baby to stay in the study and for information to be collected until age 2. Parents can say no at any time, and this won’t affect the care their babies would normally receive. Some babies given steroids will later be found to have viral meningitis; we will stop steroids as soon as this is known, as we do not expect steroids to help or harm them.
Outcomes and organisation: Parents will be asked to complete questionnaires at hospital discharge and at 12 and 24 months. We will also use information from their medical notes. The outcomes are survival and developmental difficulties (deafness, reduced vision, seizures, cerebral palsy or learning problems). We will recruit 965 babies over 4.5 years in about 60 UK hospitals, and an experienced clinical trials unit will run the study. Parents affected by meningitis and national meningitis charities helped design the study and will help share results with families, health professionals, the NHS and through meetings and medical journals.REC name
South Central - Oxford A Research Ethics Committee
REC reference
26/SC/0146
Date of REC Opinion
23 Jun 2026
REC opinion
Further Information Favourable Opinion