CRESCENT
Research type
Research Study
Full title
Seizure control via pH manipulation: a phase II double blind RCT of inhaled carbogen as adjunctive treatment of paediatric convulsive status epilepticus.
IRAS ID
1004295
Contact name
Rob Forsyth
Contact email
Sponsor organisation
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Eudract number
2021-005367-49
ISRCTN Number
ISRCTN52731862
Research summary
An epileptic seizure that is not stopping is a medical emergency. The longer it lasts the greater the risk of brain damage or even, occasionally, death. We need better ways to stop long seizures sooner. We believe creating a slightly more acidic environment within the brain may help this. One convenient and safe way to alter brain acidity is to give someone a different gas mixture to breathe. Our bodies take oxygen out of the air we breathe in; we then breathe out carbon dioxide as a “waste” gas. Carbon dioxide is very slightly acidic: if you mix a small amount (5%) with oxygen it makes the body and brain slightly acidic. This mixture is called Carbogen. It still has much more oxygen in it than room air (95% compared to 21%), and only the same amount of carbon dioxide as in the air we normally breathe out.
CRESCENT is a clinical trial for children with ongoing seizures. Half the children will receive standard drug treatment whilst breathing 100% oxygen (which is what happens currently) and the other half will receive standard drug treatment whilst inhaling Carbogen. The choice of whether a child is given Oxygen or Carbogen will be random. All children will receive the same standard medical drug treatment for their seizure.
Because this is an emergency situation, there isn’t time to give children's families information about the trial or ask if they wish to take part before the treatment is given. Families will be told that their child was in the trial and will be asked for their consent to remain in the study. This is known as “deferred consent”. We have recently successfully completed a trial of another treatment of ongoing seizures this way and found families understood and accepted this.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
22/NW/0162
Date of REC Opinion
19 Jul 2022
REC opinion
Further Information Favourable Opinion