Respiratory Physiology in Children With Febrile Seizures.
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|ClinicalTrials.gov Identifier: NCT01906619|
Recruitment Status : Unknown
Verified July 2013 by Markus Schuelke, M.D., Charite University, Berlin, Germany.
Recruitment status was: Recruiting
First Posted : July 24, 2013
Last Update Posted : July 24, 2013
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 or disease|
|Febrile Illness in Children Seizures, Febrile|
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.
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Observational Model:||Case Control|
|Official Title:||Investigation of the Respiratory Physiology of Children With and Without Febrile Seizures During Febrile Illness.|
|Study Start Date :||July 2011|
|Estimated Primary Completion Date :||July 2014|
|Estimated Study Completion Date :||December 2014|
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.
- Change of transcutaneous pCO2 per change of body temperature [mmHg/degree C] [ Time Frame: First or second night of febrile illness ]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 ]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 ]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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01906619
|Contact: Markus Schuelke, MD||+49 30 4505 firstname.lastname@example.org|
|Contact: Marret Heinold||+49 30 450 539 email@example.com|
|Charité Universitätsmedizin Berlin||Recruiting|
|Berlin, Germany, 13353|
|Contact: Markus Schuelke, MD +4 9 30 4505 66468 firstname.lastname@example.org|
|Contact: Marret Heinold +49 30 450 539 720 email@example.com|
|Principal Investigator: Markus Schuelke, MD|
|Sub-Investigator: Engelke Anne-Sophie|
|Principal Investigator:||Markus Schuelke, MD||Charite University, Berlin, Germany|