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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Charite University, Berlin, Germany
Sponsor:
Collaborator:
Charité Neurocure AG Flöel
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01370044
First received: May 20, 2011
Last updated: September 22, 2014
Last verified: September 2014

May 20, 2011
September 22, 2014
August 2012
September 2017   (final data collection date for primary outcome measure)
number of patients which need Diazepam [ Time Frame: 3 minutes ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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: 3 minutes ] [ Designated as safety issue: No ]
  • number of severe adverse events [ Time Frame: 3 minutes ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Febrile Seizure
  • Drug: Carbogen
    3 minutes administration of carbogen
  • Drug: Placebo
    3 minutes administration of 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.
 
Recruiting
288
Not Provided
September 2017   (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.)
Both
12 Months to 5 Years
No
Contact: Markus Schülke-Gerstenfeld +49 30 450 639 721 ncrc@charite.de
Germany
 
NCT01370044
CARDIF
Not Provided
Prof. Markus Schülke-Gerstenfeld, Charite University Berlin
Charite University, Berlin, Germany
Charité Neurocure AG Flöel
Principal Investigator: Markus Schülke-Gerstenfeld Charite - NeuroCure
Charite University, Berlin, Germany
September 2014

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