Respiratory Physiology in Children With Febrile Seizures.

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.

Study Overview

• Status: Unknown
• Conditions: Seizures, Febrile; Febrile Illness in Children

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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 13353
    • Recruiting
    • Charite Universitatsmedizin Berlin
    • Contact: Marret Heinold; Phone Number: +49 30 450 539 720; Email: marret.heinold@charite.de
    • Contact: Markus Schuelke, MD; Phone Number: +4 9 30 4505 66468; Email: markus.schuelke@charite.de
    • Principal Investigator: Markus Schuelke, MD
    • Sub-Investigator: Engelke Anne-Sophie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 5 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Collaborators: Sana-Klinikum Lichtenberg
• Investigators: Principal Investigator: Markus Schuelke, MD, Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (ANTICIPATED): July 1, 2014
• Study Completion (ANTICIPATED): December 1, 2014

Study Registration Dates

• First Submitted: July 20, 2013
• First Submitted That Met QC Criteria: July 23, 2013
• First Posted (ESTIMATE): July 24, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): July 24, 2013
• Last Update Submitted That Met QC Criteria: July 23, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: Respiratory physiology; Respiratory drive; Febrile Seizure; Respiratory alkalosis
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Wounds and Injuries; Body Temperature Changes; Heat Stress Disorders; Seizures; Hyperthermia; Fever; Seizures, Febrile
• Other Study ID Numbers: EA2_009_10