Respiratory Physiology in Children With Febrile Seizures.

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Charite University, Berlin, Germany
Sponsor:
Collaborator:
Sana-Klinikum Lichtenberg
Information provided by (Responsible Party):
Markus Schuelke, M.D., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01906619
First received: July 20, 2013
Last updated: July 23, 2013
Last verified: July 2013
  Purpose

Febrile seizures occur in 2-5% of the population and are typically limited to children between 3 months and 5 years-of-age. The pathophysiological link between increased body temperature and increased seizure susceptibility is unsolved in humans. In a mouse model it has been shown that young animals had a tendency to hyperventilate thereby causing intra-cerebral hypocapnia / alkalosis and a decrease of their seizure threshold. This effect was not observed in older animals. Redressing the pCO2 (carbon dioxide partial pressure) by breathing carbon dioxide enriched air instantly stopped the seizures.

In this study the investigators want to investigate the respiratory physiology in children with febrile seizures and compare it to children who have fever but did not have febrile seizures.

The investigators hypothesize that in children with febrile seizures the rising body temperature triggers a larger increase of respiratory rate (hyperventilation) and subsequent drop in pCO2 levels.

This study could provide the basic physiological data for an interventional trial to test the efficacy of carbon dioxide inhalation to interrupt febrile seizures.


Condition
Febrile Illness in Children
Seizures, Febrile

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Investigation of the Respiratory Physiology of Children With and Without Febrile Seizures During Febrile Illness.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change of transcutaneous pCO2 per change of body temperature [mmHg/degree C] [ Time Frame: First or second night of febrile illness ] [ Designated as safety issue: No ]
    The following parameters are continuously monitored in the sleeping child at night during febrile illness: body temperature, respiratory rate, transcutaneous pCO2, heart rate, pulsoxymetric SaO2

  • Change of respiratory rate per change of body temperature [1/sec * degree C] [ Time Frame: First or second night of febrile illness ] [ Designated as safety issue: No ]
    The following parameters are continuously monitored in the sleeping child at night during febrile illness: body temperature, respiratory rate, transcutaneous pCO2, heart rate, pulsoxymetric SaO2

  • Change of transcutaneous pCO2 per change of respiratory rate [mmHg * sec] [ Time Frame: First or second night of febrile illness ] [ Designated as safety issue: No ]
    The following parameters are continuously monitored in the sleeping child at night during febrile illness: body temperature, respiratory rate, transcutaneous pCO2, heart rate, pulsoxymetric SaO2


Estimated Enrollment: 100
Study Start Date: July 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Febrile illness WITH febrile seizure
The cohort comprises children aged between 3 months and 5 years who had a febrile seizure during the actual febrile disease.
Febrile illness WITHOUT febrile seizure
The cohort comprises children aged between 3 months and 5 years with a febrile illness who had never a febrile seizure.

Detailed Description:

The aim of the study is the continuous non-invasive monitoring of

  • body temperature
  • respiratory rate
  • transcutaneous pCO2
  • heart rate
  • pulsoxymetric SaO2 (arterial oxygen saturation) during a febrile illness
  • in children without febrile seizures and
  • in children who had suffered a febrile seizure during the actual febrile illness.

Children will be recruited from the emergency units of the Charité University Hospital and a large Community Hospital, matched according to age, gender and the cause of their febrile illness and their data will enter final analysis if their body temperature rose at least once to or above 38.0 degree C and changed more than 1.0 degree C during the observational period.

  Eligibility

Ages Eligible for Study:   3 Months to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Children with febrile illness between 3 months and 5 years of age with a body temperature of >38.0 during the monitoring period.

Criteria

Inclusion Criteria:

  • Febrile illness with body temperature ≥38.0 degree C
  • 50% of study population: never had a febrile seizure
  • 50% of study population: simple or complex febrile seizure within one day of investigation
  • Change of body temperature of ≥1.0 degree C during the monitoring period
  • Provision of written informed consent by the parents or guardians of the child
  • Artefact-free simultaneous measurement of respiratory rate, pCO2 (transcutaneous probe), body temperature (rectal probe), and heart rate during change of body temperature of ≥1.0 degree C.

Exclusion Criteria:

  • Past history of afebrile seizures
  • Past history of neonatal seizures
  • Retarded psychomotor development
  • Chronic respiratory disease
  • Cardiologic disease
  • Severe other organ disease
  • Permanent medication for chronic disorder
  • Therapeutic increase of inspiratory oxygen concentrations during the observational period
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01906619

Contacts
Contact: Markus Schuelke, MD +49 30 4505 66468 markus.schuelke@charite.de
Contact: Marret Heinold +49 30 450 539 720 marret.heinold@charite.de

Locations
Germany
Charité Universitätsmedizin Berlin Recruiting
Berlin, Germany, 13353
Contact: Markus Schuelke, MD    +4 9 30 4505 66468    markus.schuelke@charite.de   
Contact: Marret Heinold    +49 30 450 539 720    marret.heinold@charite.de   
Principal Investigator: Markus Schuelke, MD         
Sub-Investigator: Engelke Anne-Sophie         
Sponsors and Collaborators
Charite University, Berlin, Germany
Sana-Klinikum Lichtenberg
Investigators
Principal Investigator: Markus Schuelke, MD Charite University, Berlin, Germany
  More Information

No publications provided

Responsible Party: Markus Schuelke, M.D., Prof. Dr. med. / Prinicpal Investigator, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01906619     History of Changes
Other Study ID Numbers: EA2_009_10
Study First Received: July 20, 2013
Last Updated: July 23, 2013
Health Authority: Germany: Ministry of Health

Keywords provided by Charite University, Berlin, Germany:
Febrile Seizure
Respiratory physiology
Respiratory drive
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

ClinicalTrials.gov processed this record on August 27, 2014