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Febrile Illness in Children | Respiratory Physiology in Children With Febrile Seizures.

Febrile Illness in Children research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Febrile Illness in Children

Seizures, Febrile

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Febrile illness WITH febrile seizureThe cohort comprises children aged between 3 months and 5 years who had a febrile seizure during the actual febrile disease.

Febrile illness WITHOUT febrile seizureThe cohort comprises children aged between 3 months and 5 years with a febrile illness who had never a febrile seizure.

Study Status

Unknown status

Start Date: July 2011

Completed Date: December 2014

Phase:

Type: Observational

Design:

Primary Outcome: Change of transcutaneous pCO2 per change of body temperature [mmHg/degree C]

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Markus Schuelke, MD

Lead Sponsor: Charite University, Berlin, Germany

Collaborator: Sana-Klinikum Lichtenberg

More information:https://clinicaltrials.gov/show/NCT01906619

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