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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

Brief 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.


Condition or disease Intervention/treatment Phase
Febrile Seizure Drug: Carbogen Drug: Placebo Phase 2 Phase 3

Detailed 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]


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Carbon Dioxide (Carbogen) for the Treatment of Febrile Seizures
Study Start Date : August 2012
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever Seizures
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Verum
Verum arm receiving Carbogen
Drug: Carbogen
3 minutes administration of carbogen
Other Name: Low pressure flask with mask containing 6 L carbogen
Placebo Comparator: Placebo
Placebo arm receiving oxygen
Drug: Placebo
3 minutes administration of oxygen
Other Name: Low pressure flask with mask containing 6 L oxygen



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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)

  3. 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)

  4. contentment and anxiety of the parents [ Time Frame: 10 minutes ]
    structured interview of the parents after a seizure



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Ages Eligible for Study:   12 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01370044


Locations
Germany
Charite University Berlin
Berlin, Germany, 10107
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Principal Investigator: Markus Schülke-Gerstenfeld Charite - NeuroCure

Additional Information:
Publications:
Responsible Party: Markus Schuelke, M.D., Prof. Dr. med. Markus Schuelke, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01370044     History of Changes
Other Study ID Numbers: CARDIF
First Posted: June 9, 2011    Key Record Dates
Last Update Posted: January 26, 2018
Last Verified: January 2018

Keywords provided by Markus Schuelke, M.D., Charite University, Berlin, Germany:
Febrile Seizure
Carbon Dioxide
Carbogen
Respiratory Alkalosis

Additional relevant MeSH terms:
Seizures
Fever
Seizures, Febrile
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Body Temperature Changes