Respiratory Physiology in Children With Febrile Seizures.

NCT01906619 | Completed

• 1 other identifier: EA2_009_10
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Febrile Illness Acute; Seizures, Febrile

Keywords

Febrile Seizure; Respiratory physiology; Respiratory drive; Respiratory alkalosis

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 3 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• Febrile illness with body temperature ≥38.0 degree C
• % of study population: never had a febrile seizure
• % 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Sana-Klinikum Lichtenberg: collaborator

Study Sites (1)

Charité Universitätsmedizin Berlin

Berlin, 13353, Germany

Location

MeSH Terms

Conditions

Seizures, Febrile; Alkalosis, Respiratory

Condition Hierarchy (Ancestors)

Seizures; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperventilation; Respiration Disorders; Respiratory Tract Diseases; Alkalosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Markus Schuelke, MD

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med. / Prinicpal Investigator

Study Record Dates

• First Submitted: July 20, 2013
• First Posted: July 24, 2013
• Study Start: July 1, 2011
• Primary Completion: July 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 2, 2026

Record last verified: 2025-12

Locations

DE (1)