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CARbon DIoxide for the treatment of Febrile seizures: rationale, feasibility, and design of the CARDIF-study
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CARbon DIoxide for the treatment of Febrile seizures: rationale, feasibility, and design of the CARDIF-study
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CARbon DIoxide for the treatment of Febrile seizures: rationale, feasibility, and design of the CARDIF-study
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Journal Article
CARbon DIoxide for the treatment of Febrile seizures: rationale, feasibility, and design of the CARDIF-study
2013
Overview
Background
2-8% of all children aged between 6 months and 5 years have febrile seizures. Often these seizures cease spontaneously, however depending on different national guidelines, 20-40% of the patients would need therapeutic intervention. For seizures longer than 3-5 minutes application of rectal diazepam, buccal midazolam or sublingual lorazepam is recommended. Benzodiazepines may be ineffective in some patients or cause prolonged sedation and fatigue. Preclinical investigations in a rat model provided evidence that febrile seizures may be triggered by respiratory alkalosis, which was subsequently confirmed by a retrospective clinical observation. Further, individual therapeutic interventions demonstrated that a pCO
2
-elevation
via
re-breathing or inhalation of 5% CO
2
instantly stopped the febrile seizures. Here, we present the protocol for an interventional clinical trial to test the hypothesis that the application of 5% CO
2
is effective and safe to suppress febrile seizures in children.
Methods
The CARDIF (
CAR
bon
DI
oxide against
F
ebrile seizures) trial is a monocentric, prospective, double-blind, placebo-controlled, randomized study. A total of 288 patients with a life history of at least one febrile seizure will be randomized to receive either carbogen (5% CO
2
plus 95% O
2
) or placebo (100% O
2
). As recurrences of febrile seizures mainly occur at home, the study medication will be administered by the parents through a low-pressure can fitted with a respiratory mask. The primary outcome measure is the efficacy of carbogen to interrupt febrile seizures. As secondary outcome parameters we assess safety, practicability to use the can, quality of life, contentedness, anxiousness and mobility of the parents.
Prospect
The CARDIF trial has the potential to develop a new therapy for the suppression of febrile seizures by redressing the normal physiological state. This would offer an alternative to the currently suggested treatment with benzodiazepines. This study is an example of academic translational research from the study of animal physiology to a new therapy.
Trial registration
ClinicalTrials.gov identifier:
NCT01370044
Publisher
BioMed Central,BioMed Central Ltd,Springer Nature B.V
Subject
