Inclusion criteria | Exclusion criteria |
---|---|
1. Written informed consent from the parents or custodians of the study participant. | 1. Suspected or proven meningitis or encephalitis as a possible cause for a past cerebral seizure associated with fever. |
2. At least one febrile seizure in the past medical history of the study participant. | 2. Presence of a neurological disease or a brain malformation. |
3. Age 12 months—5 years in phase 1 and age 6 months—5 years in phase 2 of the adaptive design (after observation of 20 seizures, approximately patients number 81-288). | 4. Cerebral seizures without fever in the past medical history. |
5. Proof of spike-wave discharges or of a focus in the in the interval EEG. | |
6. Presence of a respiratory illness (e.g. bronchial asthma or bronchopulmonary dysplasia, BPD). | |
7. Presence of other severe organ or chronic diseases. | |
8. Current participation in another clinical trial. | |
9. Failure to provide written informed consent on part of the parents or custodians with regard to the storage and dissemination of pseudonymized study results. | |
10. Known adverse reactions against carbogen. | |
11. Placement of either the child or a parent/custodian in an institution, based on judicial orders. | |
12. Lack of understanding of the study procedures on part of the parents or custodians (e.g. lack of language knowledge or of general intellectual capacity). |