Febrile Illness AcuteNCT01906619
Respiratory Physiology in Children With Febrile Seizures.
An observational study of Febrile Illness Acute and Seizures, Febrile, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 months to 5 years
- Conditions the study is for
- Febrile Illness Acute, Seizures, Febrile
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2011to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 5 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Febrile Illness Acute, Seizures, Febrile
- Keywords
- Febrile Seizure, Respiratory physiology, Respiratory drive, Respiratory alkalosis
- Medical subject headings
- Seizures, Febrile, Alkalosis, Respiratory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: First or second night of febrile illness
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2013 (estimated)
- Study startJul 2011
- Primary completionJul 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Febrile Illness AcuteStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Sana-Klinikum Lichtenberg
- Responsible party
- Principal investigator, Markus Schuelke, M.D., Charite University, Berlin, Germany
- Investigators
- Markus Schuelke, MD, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01906619
- Sponsor's protocol ID
- EA2_009_10
- Status last verified
- Dec 2025
- First submitted
- 20 Jul 2013
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Respiratory Physiology of Children With and Without Febrile Seizures During Febrile Illness.
- ClinicalTrials.gov ID
- NCT01906619
- Acronym / sponsor ID
- EA2_009_10
- Conditions
- Febrile Illness Acute, Seizures, Febrile
- Keywords
- Febrile Seizure, Respiratory physiology, Respiratory drive, Respiratory alkalosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Sana-Klinikum Lichtenberg
- Study start
- Jul 2011
- Primary completion
- Jul 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 24 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 3 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- Past history of afebrile seizures
- Past history of neonatal seizures
- Retarded psychomotor development
- Chronic respiratory disease
- Cardiologic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Markus Schuelke, MD principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Febrile Illness Acute and Seizures, Febrile, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of transcutaneous pCO2 per change of body temperature [mmHg/degree C] (time frame: First or second night of febrile illness). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.