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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01370044
Recruitment Status : Terminated (results of interim analysis (not safety relevant))
First Posted : June 9, 2011
Last Update Posted : July 29, 2015
Sponsor:
Collaborator:
Information provided by:

Study Description
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

Study Design

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
Primary Completion Date : June 2015
Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

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

Arms and Interventions

Arm Intervention/treatment
Experimental: Verum
Verum arm receiving Carbogen
Drug: Carbogen
3 minutes administration of carbogen
Placebo Comparator: Placebo
Placebo arm receiving oxygen
Drug: Placebo
3 minutes administration of oxygen


Outcome Measures

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: 3 minutes ]

Eligibility Criteria

Information from the National Library of Medicine

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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.)
Contacts and Locations

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
Charité Neurocure AG Flöel
Investigators
Principal Investigator: Markus Schülke-Gerstenfeld Charite - NeuroCure
More Information

Additional Information:
Publications:
Responsible Party: Prof. Markus Schülke-Gerstenfeld, Charite University Berlin
ClinicalTrials.gov Identifier: NCT01370044     History of Changes
Other Study ID Numbers: CARDIF
First Posted: June 9, 2011    Key Record Dates
Last Update Posted: July 29, 2015
Last Verified: July 2015

Keywords provided by 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