Paediatric non-convulsive status epilepticus MedDRA version: 14.1 Level: LLT Classification code 10057769 Term: Nonconvulsive status epilepticus System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Carbogen
Product Name: 5% carbon dioxide/oxygen medical gas mixture
Pharmaceutical Form: Inhalation gas
Sponsors
Newcastle upon Tyne Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Child under sixteen with known epilepsy (i.e. established tendency to recurrent seizures) • Aetiology of epilepsy known, or investigation deemed sufficient to infer a cryptogenic (presumed symptomatic) epilepsy • No clinical suspicion of current episode being associated with acutely raised intracranial pressure • Confirmed non-convulsive status epilepticus on EEG defined as the presence of o (i) bihemispheric (ii) continuous or near-continuous (iii) spike-wave or other features indicative of seizure activity and o history from parent, or other experienced carer familiar with the patient, of lower level of awareness than normal. • Note that the presence of subtle continuing clinical seizure activity is not an exclusion criterion so long as the treating physician is satisfied that urgent treatment is not required. • Informed consent provided by parent/legal guardian Are the trial subjects under 18? yes Number of subjects for this age range: 30 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: • Age > 16 years • Absence of informed consent from parent/legal guardian • Evidence of prior chronic respiratory disease and/or type 2 respiratory failure as indicated by a baseline (pre-inhalation) capillary blood gas pCO2 > 8kPa • Any clinical suspicion of a condition associated with acutely raised intracranial pressure • Currently involved in any other clinical trial of an investigative medical product.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To assess the safety and tolerability of 5% carbogen inhalation in the context of non-convulsive status epilepticus (NCSE)in children. To seek preliminary evidence of efficacy in the form of short-term normalisation of EEG and clinical improvement during and after the period of carbogen administration.;Primary end point(s): Duration of tolerated period of carbogen inhalation ;Timepoint(s) of evaluation of this end point: Initial inhalation will be for 120 seconds. If interim analyses suggest acceptable tolerability but limited efficacy, inhalation duration may be increased to 360s or 600s at the DMECs discretion.;Main Objective: To assess the feasibility of the protocol and of data collection (blood gases, respiratory rate, breathlessness) and to confirm recruitment rates to inform the design of a definitive randomised controlled trial. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Incidence of adverse effects Recruitment rates to trial ;Timepoint(s) of evaluation of this end point: AE data will be collected on an ongoing basis. Recruitment rates will be assessed at the end of this pilot study. | — |
Countries
United Kingdom
Contacts
Public ContactChris Speed
Newcastle Clinical trials Unit
Outcome results
None listed