NCT01370044

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2012

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2011

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 9, 2011

Completed
1.1 years until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

January 26, 2018

Status Verified

January 1, 2018

Enrollment Period

2.8 years

First QC Date

May 20, 2011

Last Update Submit

January 24, 2018

Conditions

Febrile Seizure

Keywords

Febrile SeizureCarbon DioxideCarbogenRespiratory Alkalosis

Outcome Measures

Primary Outcomes (1)

  • number of patients which need Diazepam

    efficacy of a Carbogen inhalation in patients with febrile seizures compared to a placebo inhalation

    3 minutes

Secondary Outcomes (4)

  • number of severe adverse events

    3 minutes

  • manageability of the application assessed by the parents

    3 minutes

  • changes in quality of life of the parents and children after use of study medication

    3 minutes

  • contentment and anxiety of the parents

    10 minutes

Study Arms (2)

Verum

EXPERIMENTAL

Verum arm receiving Carbogen

Drug: Carbogen

Placebo

PLACEBO COMPARATOR

Placebo arm receiving oxygen

Drug: Placebo

Interventions

CarbogenDRUG

3 minutes administration of carbogen

Also known as: Low pressure flask with mask containing 6 L carbogen
Verum
PlaceboDRUG

3 minutes administration of oxygen

Also known as: Low pressure flask with mask containing 6 L oxygen
Placebo

Eligibility Criteria

Age12 Months - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • condition after febrile seizure
  • age 12 months to 5 years
  • written informed consent

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charite University Berlin

Berlin, 10107, Germany

Location

Related Publications (2)

  • 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.

    PMID: 23806032BACKGROUND

  • Weiss C, Hucko A, Muller-Ohlraun S, Marschenz S, Martus P, Schmitz D, Schuelke M. The use of carbogen for interruption of febrile seizures - the randomized controlled CARDIF trial. PLoS One. 2025 Dec 23;20(12):e0324422. doi: 10.1371/journal.pone.0324422. eCollection 2025.

    PMID: 41433250DERIVED

Related Links

MeSH Terms

Conditions

Seizures, FebrileAlkalosis, Respiratory

Interventions

carbogenOxygen

Condition Hierarchy (Ancestors)

SeizuresNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsHyperventilationRespiration DisordersRespiratory Tract DiseasesAlkalosisAcid-Base ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsGases

Study Officials

  • Markus Schülke-Gerstenfeld

    Charite - NeuroCure

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med. Markus Schuelke

Study Record Dates

First Submitted

May 20, 2011

First Posted

June 9, 2011

Study Start

August 1, 2012

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

January 26, 2018

Record last verified: 2018-01

Locations

DE(1)