febrile seizures
Conditions
Interventions
Product Name: Carbogen
Product Code: Carbogen
Pharmaceutical Form:
INN or Proposed INN: Carbon dioxide
CAS Number: 124-38-9
Other descriptive name: CARBON DIOXIDE
Concentration unit: % percent
Concen
Sponsors
Charite Universitaetsmedizin Berlin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Condition after febrile seizure - Age 12 (resp. 6) months to 5 years - Written informed consent Are the trial subjects under 18? yes Number of subjects for this age range: 288 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - severe other organic disease - meningitis as possible cause for the cerebral seizure - neurologic disease or cerebral dysplasia - cerebrale seizures without fever in the medical history - hypersynchronic eeg activity - disorder of the respiratory tract (Asthma e.g.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of a carbogen-inhalation in patients with febrile seizures compared to a placebo-inhalation;Secondary Objective: To evaluate the safety of the carbogen-inhalation via a low-pressure can with a breathing mask in a home-setting To evaluate the manageability of the arbogen-inhalation via a lowpressure can with a breathing mask in a home-setting or on the way (mobility) To evaluate the quality of life of the parents and children using the lowpressure can with a breathing mask in a home-setting or on the way (mobility) To evaluate the contentment and anxiety of the parents;Primary end point(s): Efficacy of a Carbogen inhalation defined by the number of patients with febrile seizure who needed the standard therapy (rectal Diazepam administration) after the 3 minutes Carbogen inhalation (compared to the group with Placebo inhalation);Timepoint(s) of evaluation of this end point: After 3 minutes of seizure duration | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Safety of the 6 liter Carbogen application via low pressure cans with respiratory mask in a home setting - Handling of the Carbogen low pressure cans with respiratory mask in a home setting (mobility) - Quality of life - Contentness and Anxiety of the parents;Timepoint(s) of evaluation of this end point: After 3 minutes of seizure duration | — |
Countries
Germany
Contacts
Public ContactUniversitaetsmedizin Berlin
Charite Universitaetsmedizin Berlin
Outcome results
None listed