FeverNCT04654559
Development of a Fever Detection Algorithm Based on Non-invasive Skin-based Sensor Values in Infants up to 18 Months of Age
A study testing Unobtrusive data collection using wearable non-invasive sensors in people with Fever, run by greenTEG AG at 2 sites in Switzerland.
Trial summary
Fever of infants up to 18 months of age will be monitored in the hospital using the standard clinical methods and wearable research prototypes. These research prototypes will be measuring continuously and non-invasively skin based parameters, with which the feasibility of developing a fever detection algorithm will be… Read more about this study
- Who is it for?
- Ages 2 weeks to 18 months
- Conditions the study is for
- Fever
- What is being tested?
- Unobtrusive data collection using wearable non-invasive sensors
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 7 Apr 2020to 30 Mar 2025
- Phase
- Interventional
- 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 2 weeks to 18 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants from two weeks after birth and due date up to 18 months of age
- Infants which are staying at the Nursery and the University Children's Hospital Zurich or Children's Hospital of Eastern Switzerland, St. Gallen for more than 1 day
- Informed consent signed by parents or by legal representatives
Who cannot join
- Acute medical contradiction against medical plaster and adhesives (e.g. skin diseases or allergies).
- Irritated or damaged skin (e.g. burn, rush, eczema)
- Infant with congenital anomalies (e.g. malformations of the anus)
- Disease or brain injury which cause a disturbance of the thermoregulation
- Comatose infant's
- Infants with implants (e.g. pacemaker, cochlear implants)
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Children's Hospital of Eastern Switzerland, St. Gallen
Sankt Gallen, 9000
University Children's Hospital Zurich
Zurich, 8000
About this study
Fever of infants up to 18 months of age will be monitored in the hospital using the standard clinical methods and wearable research prototypes. These research prototypes will be measuring continuously and non-invasively skin based parameters, with which the feasibility of developing a fever detection algorithm will be investigated.
Read the detailed description
Background and Rationale:
In daily clinical practice, core body temperature (CBT) of infants with fever symptoms is monitored using sporadic rectal measurements. Because these sporadic invasive measurements are time consuming for the medical staff and displeasing for patients, an alternative method to assess CBT/fever is needed. The company greenTEG is developing a CBT algorithm which calculates CBT continuously form skin temperature (ST), corresponding heat flux (HF) and other skin-based parameters. The algorithm development will be achieved by collecting skin-based parameters and reference CBT values from infants having fever in a clinical setting.
Objective(s):
Develop and validate an algorithm that allows the detection of fever in infants through a non-invasive sensor system, which calculates CBT from ST, HF and other skin-based data streams, allowing a more effective patient management.
Statistical Considerations:
The measures of quality will be: 1) The mean absolute difference (MAD) between the CBT prediction and the reference signal where the mean is taken over the whole measurement of a single patient. An aggregate performance measure over a group of patients is defined by averaging the MAD values of each patient in the group. 2) the 2σ (standard deviation) range of the Bland-Altmann-Plot between the CBT prediction and the reference signal. This is calculated either for individual patient data or for the combined data of all patients together. As we have defined a group of patients for algorithm validation, the total improvement will be defined by comparing the above aggregate performance measures of old and new algorithm for the validation group. We expect the factors age, sex to influence the algorithmic prediction. Balancing the probability of occurrence of the factors in the population and the overall size of the study, a final size of 50 patients is reasonable.
Study procedures:
Infants will be recruited and screened 1 days before the measurements starts. Two research prototypes will be applied to the patient on the left side of the body (lateral ribcage and foot), after being admitted to the hospital and parents having signed the informed consent. For all infants rectal measurement will be asses every 8 hours, as reference temperature. For infants older than 6 months, in addition to rectal temperature, ear temperature will be assessed every 4 hours with an infrared ear thermometer. The whole measurement procedure will last 18-72 hours, depending on the stationary stay of the individual patient.
- Conditions
- Fever
- Being tested
- Unobtrusive data collection using wearable non-invasive sensors
- Keywords
- core body temperature, fever, wearable
- Medical subject headings
- Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unobtrusive data collection using wearable non-invasive sensorsOther
Two wearable non-invasive sensors will be mounted to the patients skin (lateral rib cage and foot). These wearable non-invasive sensors are measuring unobtrusively skin based parameters (no diagnosis will be made), which will be used for fever detection algorithm development..
| Study group | Role | What they receive |
|---|---|---|
| Unobtrusive data collection | Other | Not described Receives: Other: Unobtrusive data collection using wearable non-invasive sensors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Continuous and non-invasive skin temperature at the lateral rib cage position
Skin temperature data collected continuously and non-invasively using a research prototype at the lateral ribcage. The skin temperature is measured directly underneath the research prototype on the surface of the skin in degree Celsius.
Measured: Participants will be monitored continuously and unobtrusively with the research prototypes over a 1-3 day time period, depending on the stationary stay in the hospital
Continuous and non-invasive heat flux at the lateral rib cage position
Heat flux data collected continuously and non-invasively using a research prototype at the lateral ribcage. Most of this heat flux will be the thermal energy transmitted from the participants body and is measured in watts per square meters.
Measured: Participants will be monitored continuously and unobtrusively with the research prototypes over a 1-3 day time period, depending on the stationary stay in the hospital
Continuous and non-invasive skin temperature at the foot position
Skin temperature data collected continuously and non-invasively using a research prototype at the foot. The skin temperature is measured directly underneath the research prototype on the surface of the skin in degree Celsius.
Measured: Participants will be monitored continuously and unobtrusively with the research prototypes over a 1-3 day time period, depending on the stationary stay in the hospital
Continuous and non-invasive heat flux at the lateral foot position
Heat flux data collected continuously and non-invasively using a research prototype at the foot. Most of this heat flux will be the thermal energy transmitted from the participants body and is measured in watts per square meters.
Measured: Participants will be monitored continuously and unobtrusively with the research prototypes over a 1-3 day time period, depending on the stationary stay in the hospital
Sporadic rectal temperature measurement
Rectal temperature will be measured every 8 hours by medical staff using the clinically established method of the hospital. This is a standard clinical routine and the precise timing of this measurement is determined by the medical staff according to their daily work routine.
Measured: Every 8 hours over a 1-3 day time period, depending on the stationary stay in the hospital
Sporadic ear temperature measurements
For infants older than 6 months of age only: Ear temperature will be measured every 4 hours using an infrared ear thermometer. The every second ear temperature measurement will coincide with the rectal temperature measurement.
Measured: Every 4 hours over a 1-3 day time period, depending on the stationary stay in the hospital
Secondary outcomes (2)
Heart rate
Heart rate [beats per minute] will be collected using the research prototype on the foot
Measured: Participants will be monitored continuously and unobtrusively with the research prototypes over a 1-3 day time period, depending on the stationary stay in the hospital
SpO2
Oxygen saturation (SpO2) will be collected using the research prototype on the foot
Measured: Participants will be monitored continuously and unobtrusively with the research prototypes over a 1-3 day time period, depending on the stationary stay in the hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start7 Apr 2020
- Primary completion30 Mar 2025 (estimated)
- Study completion30 Mar 2025 (estimated)
Why it stopped: Temporary stop \& analyze current data. Study may be resumed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FeverStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- greenTEG AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Children's Hospital, Zurich, Department of Child Development, Children's Hospital St. Gallen, Switzerland
- Responsible party
- Sponsor
- Investigators
- Christoph Berger, Prof. Dr., Principal investigator, University Children's Hospital, Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04654559
- Sponsor's protocol ID
- 6058_Baby_study_1
- Status last verified
- Mar 2024
- First submitted
- 26 Nov 2020
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The results of this study will be published in a suited journal. Publication strategy is still in discussion.
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Fever Detection Algorithm Based on Non-invasive Skin-based Sensor Values in Infants up to 18 Months of Age
- ClinicalTrials.gov ID
- NCT04654559
- Acronym / sponsor ID
- 6058_Baby_study_1
- Conditions
- Fever
- Keywords
- core body temperature, fever, wearable
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Temporary stop \& analyze current data. Study may be resumed.
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- greenTEG AGIndustry (pharma, biotech, devices)
- Collaborators
- University Children's Hospital, Zurich, Department of Child Development, Children's Hospital St. Gallen, Switzerland
- Study start
- 7 Apr 2020 (actual)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 4 Dec 2020 (actual)
- 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.
Fever of infants up to 18 months of age will be monitored in the hospital using the standard clinical methods and wearable research prototypes. These research prototypes will be measuring continuously and non-invasively skin based parameters, with which the feasibility of developing a fever detection algorithm will be investigated.
Detailed description
Background and Rationale:
In daily clinical practice, core body temperature (CBT) of infants with fever symptoms is monitored using sporadic rectal measurements. Because these sporadic invasive measurements are time consuming for the medical staff and displeasing for patients, an alternative method to assess CBT/fever is needed. The company greenTEG is developing a CBT algorithm which calculates CBT continuously form skin temperature (ST), corresponding heat flux (HF) and other skin-based parameters. The algorithm development will be achieved by collecting skin-based parameters and reference CBT values from infants having fever in a clinical setting.
Objective(s):
Develop and validate an algorithm that allows the detection of fever in infants through a non-invasive sensor system, which calculates CBT from ST, HF and other skin-based data streams, allowing a more effective patient management.
Statistical Considerations:
The measures of quality will be: 1) The mean absolute difference (MAD) between the CBT prediction and the reference signal where the mean is taken over the whole measurement of a single patient. An aggregate performance measure over a group of patients is defined by averaging the MAD values of each patient in the group. 2) the 2σ (standard deviation) range of the Bland-Altmann-Plot between the CBT prediction and the reference signal. This is calculated either for individual patient data or for the combined data of all patients together. As we have defined a group of patients for algorithm validation, the total improvement will be defined by comparing the above aggregate performance measures of old and new algorithm for the validation group. We expect the factors age, sex to influence the algorithmic prediction. Balancing the probability of occurrence of the factors in the population and the overall size of the study, a final size of 50 patients is reasonable.
Study procedures:
Infants will be recruited and screened 1 days before the measurements starts. Two research prototypes will be applied to the patient on the left side of the body (lateral ribcage and foot), after being admitted to the hospital and parents having signed the informed consent. For all infants rectal measurement will be asses every 8 hours, as reference temperature. For infants older than 6 months, in addition to rectal temperature, ear temperature will be assessed every 4 hours with an infrared ear thermometer. The whole measurement procedure will last 18-72 hours, depending on the stationary stay of the individual patient.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Unobtrusive data collection | Other | Other: Unobtrusive data collection using wearable non-invasive sensors |
Who may qualify
- Ages
- 2 weeks to 18 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Infants from two weeks after birth and due date up to 18 months of age
- Infants which are staying at the Nursery and the University Children's Hospital Zurich or Children's Hospital of Eastern Switzerland, St. Gallen for more than 1 day
- Informed consent signed by parents or by legal representatives
Key exclusion criteria (6 listed)
- Acute medical contradiction against medical plaster and adhesives (e.g. skin diseases or allergies).
- Irritated or damaged skin (e.g. burn, rush, eczema)
- Infant with congenital anomalies (e.g. malformations of the anus)
- Disease or brain injury which cause a disturbance of the thermoregulation
- Comatose infant's
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unobtrusive data collection using wearable non-invasive sensorsTwo wearable non-invasive sensors will be mounted to the patients skin (lateral rib cage and foot). These wearable non-invasive sensors are measuring unobtrusively skin based parameters (no diagnosis will be made), which will be used for fever detection algorithm development.. | Other | Unobtrusive data collection |
Primary outcome
Continuous and non-invasive skin temperature at the lateral rib cage position
Time frame: Participants will be monitored continuously and unobtrusively with the research prototypes over a 1-3 day time period, depending on the stationary stay in the hospital
Skin temperature data collected continuously and non-invasively using a research prototype at the lateral ribcage. The skin temperature is measured directly underneath the research prototype on the surface of the skin in degree Celsius.
Continuous and non-invasive heat flux at the lateral rib cage position
Time frame: Participants will be monitored continuously and unobtrusively with the research prototypes over a 1-3 day time period, depending on the stationary stay in the hospital
Heat flux data collected continuously and non-invasively using a research prototype at the lateral ribcage. Most of this heat flux will be the thermal energy transmitted from the participants body and is measured in watts per square meters.
Continuous and non-invasive skin temperature at the foot position
Time frame: Participants will be monitored continuously and unobtrusively with the research prototypes over a 1-3 day time period, depending on the stationary stay in the hospital
Skin temperature data collected continuously and non-invasively using a research prototype at the foot. The skin temperature is measured directly underneath the research prototype on the surface of the skin in degree Celsius.
Continuous and non-invasive heat flux at the lateral foot position
Time frame: Participants will be monitored continuously and unobtrusively with the research prototypes over a 1-3 day time period, depending on the stationary stay in the hospital
Heat flux data collected continuously and non-invasively using a research prototype at the foot. Most of this heat flux will be the thermal energy transmitted from the participants body and is measured in watts per square meters.
Sporadic rectal temperature measurement
Time frame: Every 8 hours over a 1-3 day time period, depending on the stationary stay in the hospital
Rectal temperature will be measured every 8 hours by medical staff using the clinically established method of the hospital. This is a standard clinical routine and the precise timing of this measurement is determined by the medical staff according to their daily work routine.
Sporadic ear temperature measurements
Time frame: Every 4 hours over a 1-3 day time period, depending on the stationary stay in the hospital
For infants older than 6 months of age only: Ear temperature will be measured every 4 hours using an infrared ear thermometer. The every second ear temperature measurement will coincide with the rectal temperature measurement.
2 secondary outcomes
Heart rate
Time frame: Participants will be monitored continuously and unobtrusively with the research prototypes over a 1-3 day time period, depending on the stationary stay in the hospital
SpO2
Time frame: Participants will be monitored continuously and unobtrusively with the research prototypes over a 1-3 day time period, depending on the stationary stay in the hospital
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Individual participant dataSharing planned: Undecided. The results of this study will be published in a suited journal. Publication strategy is still in discussion.
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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.
Christoph Berger, Prof. Dr. principal investigator
University Children's Hospital, Zurich
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unobtrusive data collection using wearable non-invasive sensors in people with Fever, run by greenTEG AG at 2 sites in Switzerland.
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 3 inclusion and 6 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: paused, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. 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?
Results are not available in the source record.
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?
Continuous and non-invasive skin temperature at the lateral rib cage position (time frame: Participants will be monitored continuously and unobtrusively with the research prototypes over a 1-3 day time period, depending on the stationary stay in the hospital). The study lists 6 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 15 Mar 2024.