Babies with suspected meningitis to receive steroids in new trial

A new trial will see if giving steroids to babies with suspected bacterial meningitis improves survival and long-term outcomes.

The trial is known as Better Outcomes in Babies with Bacterial meningitis (BOBBi). It will investigate whether this treatment helps more babies survive without long-term difficulties.

Patients will take part across the country, including at University Hospital Southampton (UHS).

Preventing long-term problems

Bacterial meningitis affects about 350 babies every year in the UK. Even with treatment, around one in 20 of these babies die.

Of those who survive, one in three have long-term problems. These include deafness, cerebral palsy and learning difficulties.

In older children with bacterial meningitis, steroids can reduce serious long term problems. However, it is not yet known whether steroids can help babies under three months old.

Comparing outcomes

The BOBBi trial will include more than 1,000 babies. It will take place across 60 hospitals in the UK and 14 hospitals in Canada over the next four and a half years.

Babies taking part will be randomly assigned to two groups. One group will get a steroid (dexamethasone) as well as usual care (antibiotics). The other group will get usual care without the steroid.

The trial will compare outcomes between babies in the two groups, to see if there is a difference.

The researchers will follow up with babies in the trial until they are two years old. This is to see if there are any long term effects on health, learning, or development of giving steroids for meningitis.

Providing new evidence

Dr Katrina Cathie is leading the trial in Southampton. She is a Consultant in General Paediatrics and Paediatric Research. She is also the Associate Director for Paediatrics at the NIHR Southampton Clinical Research Facility. She said:

“Bacterial meningitis is a rare but devastating illness that still affects babies in the UK and abroad. There can be significant consequences for the child and family due to long term complications.

“This study will look at whether the addition of another simple treatment (steroids) at the time the baby is diagnosed can help improve their outcomes.

“We are delighted to be participating at UHS, and some of our team have been involved in the design of the study.”

The trial 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 (POPCORN) research platform in Canada.

Professor Paul Heath is Professor of Paediatric Infectious Diseases at City St George's, University of London. He said:

“Bacterial meningitis is greatly feared by parents and the public, and by 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.

“The BOBBi trial provides a unique opportunity to test if giving steroids to babies with bacterial meningitis means more of them will survive without long term difficulties.

“BOBBi will therefore provide the definitive evidence needed to update meningitis guidelines on the use of steroids in young infants.”