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Carbon Dioxide (Carbogen) for the Treatment of Febrile Seizures (CARDIF)

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ClinicalTrials.gov Identifier: NCT01370044
Recruitment Status : Terminated (results of interim analysis (not safety relevant))
First Posted : June 9, 2011
Last Update Posted : January 26, 2018
Sponsor:
Information provided by (Responsible Party):
Markus Schuelke, M.D., Charite University, Berlin, Germany

May 20, 2011
June 9, 2011
January 26, 2018
August 2012
June 2015   (Final data collection date for primary outcome measure)
number of patients which need Diazepam [ Time Frame: 3 minutes ]
efficacy of a Carbogen inhalation in patients with febrile seizures compared to a placebo inhalation
Same as current
Complete list of historical versions of study NCT01370044 on ClinicalTrials.gov Archive Site
  • number of severe adverse events [ Time Frame: 3 minutes ]
    safety of the Carbogen inhalation via a low-pressure can with a breathing mask in a home-setting
  • manageability of the application assessed by the parents [ Time Frame: 3 minutes ]
    manageability of the Carbogen inhalation via a low pressure can with a breathing mask in a home-setting or on the way (mobility)
  • changes in quality of life of the parents and children after use of study medication [ Time Frame: 3 minutes ]
    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)
  • contentment and anxiety of the parents [ Time Frame: 10 minutes ]
    structured interview of the parents after a seizure
  • number of severe adverse events [ Time Frame: 3 minutes ]
    safety of the Carbogen inhalation via a low-pressure can with a breathing mask in a home-setting
  • manageability of the application assessed by the parents [ Time Frame: 3 minutes ]
    manageability of the Carbogen inhalation via a lowpressure can with a breathing mask in a home-setting or on the way (mobility)
  • changes in quality of life of the parents and children after use of studymedication [ Time Frame: 3 minutes ]
    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)
  • contentment and anxiety of the parents [ Time Frame: 3 minutes ]
Not Provided
Not Provided
 
Carbon Dioxide (Carbogen) for the Treatment of Febrile Seizures
Carbon Dioxide (Carbogen) for the Treatment of Febrile Seizures

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.

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]

Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Febrile Seizure
  • Drug: Carbogen
    3 minutes administration of carbogen
    Other Name: Low pressure flask with mask containing 6 L carbogen
  • Drug: Placebo
    3 minutes administration of oxygen
    Other Name: Low pressure flask with mask containing 6 L oxygen
  • Experimental: Verum
    Verum arm receiving Carbogen
    Intervention: Drug: Carbogen
  • Placebo Comparator: Placebo
    Placebo arm receiving oxygen
    Intervention: Drug: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
96
288
June 2015
June 2015   (Final data collection date for primary outcome measure)

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.)
Sexes Eligible for Study: All
12 Months to 5 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01370044
CARDIF
Not Provided
Not Provided
Not Provided
Markus Schuelke, M.D., Charite University, Berlin, Germany
Charite University, Berlin, Germany
Not Provided
Principal Investigator: Markus Schülke-Gerstenfeld Charite - NeuroCure
Charite University, Berlin, Germany
January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP