Carbon Dioxide (Carbogen) for the Treatment of Febrile Seizures

Febrile Seizure Clinical Trial

— CARDIF  

Official title:

Carbon Dioxide (Carbogen) for the Treatment of Febrile Seizures

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01370044
• Other study ID #: CARDIF
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: May 20, 2011
• Last updated: January 24, 2018
• Start date: August 2012
• Est. completion date: June 2015

Study information

• Verified date: January 2018
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this clinical trail is to evaluate the efficacy of a Carbogen inhalation in patients with febrile seizures compared to a placebo-inhalation.

Further aims are the evaluation of the safety of the Carbogen inhalation via a low-pressure can with a breathing mask in a home-setting, the manageability of the Carbogen inhalation via a low pressure can with a breathing mask in a home-setting or on the way (mobility), the quality of life of the parents and children using the low pressure can with a breathing mask in a home-setting or on the way (mobility) and the contentment and anxiety of the parents.

Description:

For detailed protocol see:

Ohlraun S, Wollersheim T, Weiß C, Martus P, Weber-Carstens S, Schmitz D, Schuelke M. CARbon DIoxide for the treatment of Febrile seizures: rationale, feasibility, and design of the CARDIF-study. J Transl Med. 2013 Jun 27;11:157. doi: 10.1186/1479-5876-11-157.

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 pCO2-elevation via re-breathing or inhalation of 5% CO2 instantly stopped the febrile seizures. Here, we present the protocol for an interventional clinical trial to test the hypothesis that the application of 5% CO2 is effective and safe to suppress febrile seizures in children.

METHODS: The CARDIF (CARbon DIoxide against Febrile 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% CO2 plus 95% O2) or placebo (100% O2). 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. DOI: 10.1186/1479-5876-11-157 PMCID: PMC3700755 PMID: 23806032 [Indexed for MEDLINE]

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 96
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Months to 5 Years

Eligibility

Inclusion Criteria:

• condition after febrile seizure

• age 12 months to 5 years

• written informed consent

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.)

Related Conditions & MeSH terms

• Febrile Seizure
• Fever
• Seizures
• Seizures, Febrile

Intervention

Drug:
• Carbogen
3 minutes administration of carbogen
• Placebo
3 minutes administration of oxygen

Locations

Country	Name	City	State
Germany	Charite University Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Ohlraun S, Wollersheim T, Weiß C, Martus P, Weber-Carstens S, Schmitz D, Schuelke M. CARbon DIoxide for the treatment of Febrile seizures: rationale, feasibility, and design of the CARDIF-study. J Transl Med. 2013 Jun 27;11:157. doi: 10.1186/1479-5876-11-157. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of patients which need Diazepam	efficacy of a Carbogen inhalation in patients with febrile seizures compared to a placebo inhalation	3 minutes
Secondary	number of severe adverse events	safety of the Carbogen inhalation via a low-pressure can with a breathing mask in a home-setting	3 minutes
Secondary	manageability of the application assessed by the parents	manageability of the Carbogen inhalation via a low pressure can with a breathing mask in a home-setting or on the way (mobility)	3 minutes
Secondary	changes in quality of life of the parents and children after use of study medication	quality of life of the parents and children using the low pressure can with a breathing mask in a home-setting or on the way (mobility)	3 minutes
Secondary	contentment and anxiety of the parents	structured interview of the parents after a seizure	10 minutes

External Links

•   Homepage of the NeuroCure Clinical Resaerch Center at the Charité Berlin