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

This study is currently recruiting participants.
Verified March 2014 by Charite University, Berlin, Germany
Sponsor:
Collaborator:
NeuroCure
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01370044
First received: May 20, 2011
Last updated: March 19, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
Febrile Seizure
Drug: Carbogen
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Carbon Dioxide (Carbogen) for the Treatment of Febrile Seizures

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 288
Study Start Date: August 2012
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   12 Months to 5 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01370044

Contacts
Contact: Markus Schülke-Gerstenfeld +49 30 450 639 721 ncrc@charite.de

Locations
Germany
Charite University Berlin Recruiting
Berlin, Germany, 10107
Contact: Markus Schülke-Gerstenfeld    +49 30 450 639 721    ncrc@charite.de   
Principal Investigator: Markus Schülke-Gerstenfeld         
Sponsors and Collaborators
Charite University, Berlin, Germany
NeuroCure
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
Study First Received: May 20, 2011
Last Updated: March 19, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Charite University, Berlin, Germany:
Febrile Seizure
Carbon Dioxide
Carbogen
Respiratory Alkalosis

Additional relevant MeSH terms:
Seizures, Febrile
Fever
Seizures
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Body Temperature Changes
Signs and Symptoms
Neurologic Manifestations
Carbogen
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014