RecruitingPhase IIIInterventional

Better outcomes in babies with bacterial meningitis

Bacterial meningitis is a rare but life-threatening infection of the lining around the brain and spinal cord. Even with prompt antibiotic care, babies under three months old are at risk of death or lasting complications, including hearing loss and developmental delay. In older children, adding a steroid medicine called dexamethasone to standard antibiotic treatment helps reduce brain swelling and protects against disability. However, doctors do not yet know if it is safe and helpful for newborn babies. The BOBBi trial aims to find out if dexamethasone improves recovery for young babies. Because meningitis requires urgent treatment, babies are started on treatment right away, and parents are spoken to within 48 hours to discuss ongoing participation. Researchers will follow up on each baby's development up to two years of age to understand the long-term benefits.

At a glance

Status

Recruiting

Phase

Phase III

Sponsor

City St George's, University of London

Enrolment target

965

Start

09 Oct 2026

Estimated completion

30 Nov 2030

Bacterial meningitis (BM)

What is this study about?

Bacterial meningitis is an infection of the protective layers covering the brain and spinal cord. It is a medical emergency that can make young babies very poorly very quickly. While antibiotics are essential and save lives, the body's natural inflammatory response to the infection can sometimes cause lasting harm to the brain. In young babies, this can lead to lifelong challenges with hearing, sight, movement, or learning.

In older children and adults, doctors often give a steroid medicine called dexamethasone alongside antibiotics. Steroids work by calming down swelling and inflammation in the brain, which lowers the chance of long-term disability. However, because newborn babies have different immune systems and developing organs, doctors are not certain whether steroids offer the same protection to them, or if the risks outweigh the benefits.

The BOBBi study has been set up to resolve this question. By comparing babies who receive dexamethasone with those who receive standard antibiotic care alone, doctors hope to find the safest and most effective way to care for babies with this infection in the future. The trial has been designed with the help of parents and charities to ensure it is handled with the utmost care and sensitivity.

Key takeaways

The BOBBi trial is testing whether the steroid dexamethasone helps babies under three months recover from bacterial meningitis.
Steroids protect older children from hearing loss and brain injury, but doctors need to know if they are safe and helpful for tiny babies.
Treatment starts quickly in the emergency room, and doctors approach parents within 48 hours to discuss ongoing consent.
Babies are followed up using simple parent questionnaires until they reach two years old.
Joining is voluntary, and you can withdraw your baby at any point without impacting their standard NHS care.

Who may be eligible?

This study is for babies up to three months of age who doctors suspect or confirm have bacterial meningitis and are starting antibiotic treatment.

Babies born prematurely can also take part. If a baby was born between 34 and 36 weeks, their age is adjusted for their due date (up to three months corrected age). Babies born before 34 weeks can take part once they are at least seven days old and have reached the equivalent of 32 weeks of pregnancy.

Babies cannot take part if more than 12 hours have passed since they started their antibiotics for meningitis, or if they have previously had brain surgery or a brain shunt fitted.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

My baby is under 3 months old (or under 3 months corrected age if born premature).
My baby has suspected or confirmed bacterial meningitis.
My baby is starting or has recently started antibiotics (within the last 12 hours).
My baby has not had previous brain surgery or a shunt fitted.
If born before 34 weeks, my baby is at least 7 days old.

Answer every question to see your result.

What does participation involve?

If your baby takes part, they will be randomly placed by a computer into one of two groups. One group receives the steroid dexamethasone alongside standard antibiotics, while the other group receives standard antibiotics alone. Treatment must begin immediately, so your baby may be enrolled just before doctors discuss the study with you. A doctor or research nurse will speak to you, usually within 48 hours, to explain everything and ask for your permission for your baby to stay in the study.

Your baby's care in the hospital will be closely monitored. If later test results show that your baby does not have bacterial meningitis after all, the trial treatment will be stopped immediately.

Taking part will not require extra hospital visits after discharge. Instead, you will be asked to fill in short questionnaires when you leave the hospital, and again when your baby is 12 months and 24 months old. These check on your baby's growth, hearing, vision, and general development. In total, your baby will be followed up until their second birthday.

Potential risks and benefits

The potential benefit of taking part is that your baby might receive a treatment that reduces brain inflammation and lowers the risk of hearing loss or learning difficulties, while helping doctors discover better care for future babies. However, dexamethasone can cause side effects, such as temporarily raised blood sugar levels or, rarely, mild bleeding in the stomach. Doctors will watch your baby very closely to catch and treat any issues. Taking part is completely voluntary, and you have the right to withdraw your baby at any time without your child's NHS care or treatment being affected in any way.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Not provided at time of registration
City only
-, England
Not provided at time of registration
City only
-, Canada

Common questions

Why was my baby enrolled before I gave permission?

Bacterial meningitis is an emergency where every minute matters. To give the steroid the best chance of working without delaying life-saving care, researchers use an approach called 'deferred consent'. This allows treatment to start immediately, and a doctor will speak with you as soon as your baby is stable, usually within 48 hours.

What happens if my baby does not actually have meningitis?

Doctors often start treatment based on early symptoms while waiting for laboratory results. If lab tests confirm that your baby does not have bacterial meningitis, the trial medicine will be stopped straight away.

Will taking part change my baby's main medical care?

No. All babies in the trial receive full, standard NHS care, including all necessary antibiotics and close monitoring in hospital. The only difference is whether or not they receive the steroid dexamethasone.

What extra appointments will we have to attend?

There are no extra hospital appointments specifically for the trial. Follow-up is done through questionnaires that you can complete at home when your baby is 12 and 24 months old.

Can I choose to stop taking part later on?

Yes. You can withdraw your baby from the study at any time, for any reason. Doing so will not affect the quality of care or treatment your baby receives from the medical team.

How to find out more

Vasha Bari

bobbi@npeu.ox.ac.uk +44 (0)1865 289437 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.