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

This study is currently recruiting participants.

Verified August 2012 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: January 8, 2013

Last verified: August 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

May 20, 2011

Last Updated Date

January 8, 2013

Start Date ^ICMJE

August 2012

Estimated Primary Completion Date

November 2016 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01370044 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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 ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Carbon Dioxide (Carbogen) for the Treatment of Febrile Seizures

Official Title ^ICMJE

Carbon Dioxide (Carbogen) for the Treatment of Febrile Seizures

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2
Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Febrile Seizure

Intervention ^ICMJE

Drug: Verum arm receiving Carbogen
3 minutes administration of carbogen
Drug: Placebo
3 minutes administration of oxygen

Study Arm (s)

Experimental: Verum
Verum arm receiving Carbogen

Intervention: Drug: Verum arm receiving Carbogen
Placebo Comparator: Placebo
Placebo arm receiving oxygen

Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

288

Completion Date

Not Provided

Estimated Primary Completion Date

November 2016 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.)

Gender

Both

Ages

12 Months to 5 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Markus Schülke-Gerstenfeld

+49 30 450 639 721

ncrc@charite.de

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT01370044

Other Study ID Numbers ^ICMJE

CARDIF

Has Data Monitoring Committee

Not Provided

Responsible Party

Prof. Markus Schülke-Gerstenfeld, Charite University Berlin

Study Sponsor ^ICMJE

Charite University, Berlin, Germany

Collaborators ^ICMJE

NeuroCure

Investigators ^ICMJE

Principal Investigator:

Markus Schülke-Gerstenfeld

Charite - NeuroCure

Information Provided By

Charite University, Berlin, Germany

Verification Date

August 2012

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

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