Skip to main content
OpenTrials
Completed

NCT Number: NCT01906619

Respiratory Physiology in Children With Febrile Seizures.

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

3 month–5 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Charité Universitätsmedizin Berlin

Berlin, 13353, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • Sana-Klinikum Lichtenberg

Registry information

Official study title

Investigation of the Respiratory Physiology of Children With and Without Febrile Seizures During Febrile Illness.

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jul 24, 2013
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.