New clinical trial opening in treatment of status epilepticus

Dr Rob Forsyth, study lead, shares more about the upcoming CRESCENT trial

Status epilepticus (a seizure that lasts over five minutes and is showing no signs of stopping) is a familiar medical emergency for Dravet families. CRESCENT is a new randomised clinical trial that will be opening in Emergency Departments in several large Children's Hospitals in the next couple of months and running for the next 2-3 years. If you care for a child with Dravet and your local hospital is in Newcastle upon Tyne, Sunderland, Liverpool (Alder Hey), Leeds, Birmingham, Nottingham, Bristol or Brighton you may come across the study.

Its aim is to see whether slightly altering the medical gas a child is given to breathe whilst treating their status makes the standard medications more effective, with more children responding to first line treatment. For the first ten minutes after arrival only, children will either be given 100% oxygen (which is what happens currently) or 95% oxygen 5% carbon dioxide, a mixture known as carbogen. After ten minutes if oxygen is still needed the doctors will switch to the hospital piped supply.

Carbogen is widely used in other hospital settings (e.g. radiotherapy departments) and is very safe. The level of carbon dioxide (5%) is the same as in the air we breathe out. CRESCENT is what is known as a double-blind study: neither you nor the treating doctors will know which of the two gasses is being given.

Importantly, because this is an emergency situation we don't have time to discuss and get families' agreement to involvement beforehand. We have had approval to explain the study *afterwards* and ask families' permission to use the data on outcome collected (an approach called "deferred consent"). We have agreement to do this because this is the only way research can be done in emergency situations, and so the only way we can find better emergency treatments. Your child would only be involved in CRESCENT once even if they had more than one episode of status during the time the study was running.

There's more information about the study, including information about how to contact the study team if you have any questions, at https://www.crescent-trial.org.uk

The CRESCENT trial is an independent study and is not funded by DSUK.