Febrile Illness in Children Clinical Trial
Official title:
Investigation of the Respiratory Physiology of Children With and Without Febrile Seizures During Febrile Illness.
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.
| Status | Recruiting |
| Enrollment | 100 |
| Est. completion date | December 2014 |
| Est. primary completion date | July 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 3 Months to 5 Years |
| Eligibility |
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 |
Observational Model: Case Control, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Germany | Charité Universitätsmedizin Berlin | Berlin |
| Lead Sponsor | Collaborator |
|---|---|
| Charite University, Berlin, Germany | Sana-Klinikum Lichtenberg |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change of transcutaneous pCO2 per change of body temperature [mmHg/degree C] | 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 | First or second night of febrile illness | No |
| Primary | Change of respiratory rate per change of body temperature [1/sec * degree C] | 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 | First or second night of febrile illness | No |
| Primary | Change of transcutaneous pCO2 per change of respiratory rate [mmHg * sec] | 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 | First or second night of febrile illness | No |