A new trial will investigate whether giving steroids to babies with suspected bacterial meningitis means that more babies will survive without long-term difficulties.
Published
The Better Outcomes in Babies with Bacterial meningitis (BOBBi) trial will include more than 1000 babies and will take place across 60 hospitals in the UK and 14 hospitals in Canada over the next four and a half years.
Bacterial meningitis affects about 350 babies every year in the UK. Even with treatment, around one in 20 of these babies die and one in three who survive have long-term problems like deafness, cerebral palsy and significant developmental difficulties. In older children with bacterial meningitis, steroids can reduce serious long-term problems, but it is not yet known whether steroids can help babies under three months old.
The BOBBi trial will find out if giving steroids to babies with suspected bacterial meningitis, in addition to receiving their usual treatment of antibiotics, means more babies survive without long term difficulties. Babies will be randomly split into two groups - one group will get a steroid (dexamethasone) alongside usual care, and the other group will get usual care without the steroid.
The trial, led by City St George’s, is being run by the National Perinatal Epidemiology Unit (NPEU) Clinical Trials Unit at Oxford Population Health and the Pediatric Outcome Improvement through Coordination of Research Networks research platform in Canada.
Professor Paul Heath, Professor of Paediatric Infectious Diseases at City St George's School of Health and Medical Sciences, said:
“Bacterial meningitis is greatly feared by parents, the public, doctors and nurses. There are no new treatments available to improve the outcomes of meningitis other than steroids, which are currently only recommended in older age groups."
Babies in the trial will be followed up until they are two years old to see if there are any long-term effects on health, learning or development of giving steroids for meningitis. The study will compare outcomes between babies who received steroids with those who did not to see if there is a difference.
Pollyanna Hardy, Associate Professor and Director of the NPEU Clinical Trials Unit said:
Group B Strep Support (GBSS) and Meningitis Research Foundation (MRF) are working closely with the BOBBi trial team to ensure that the voices and experiences of families affected by bacterial meningitis are at the heart of the research. Both charities are supporting the trial by helping to shape trial materials, raise awareness among families and ensure the research addresses the real-world needs of parents and babies.