Development of a Fever Detection Algorithm Based on Non-invasive Skin-based Sensor Values in Infants up to 18 Months of Age

Fever Clinical Trial

Official title:

Development of a Fever Detection Algorithm Based on Non-invasive Skin-based Sensor Values in Infants up to 18 Months of Age

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04654559
• Other study ID #: 6058_Baby_study_1
• Status: Suspended
• Phase: N/A
• Start date: April 7, 2020
• Est. completion date: March 30, 2025

Study information

• Verified date: March 2024
• Source: greenTEG AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 investigated.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 50
• Est. completion date: March 30, 2025
• Est. primary completion date: March 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Weeks to 18 Months

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Fever

Intervention

Other:
• Unobtrusive data collection using wearable non-invasive sensors
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..

Locations

Country	Name	City	State
Switzerland	Children's Hospital of Eastern Switzerland, St. Gallen	Saint Gallen
Switzerland	University Children's Hospital Zurich	Zurich

Sponsors (3)

Lead Sponsor	Collaborator
greenTEG AG	Children's Hospital of Eastern Switzerland, St. Gallen, University Children's Hospital, Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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
Primary	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.	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
Primary	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.	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
Primary	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.	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
Primary	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.	Every 8 hours over a 1-3 day time period, depending on the stationary stay in the hospital
Primary	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.	Every 4 hours over a 1-3 day time period, depending on the stationary stay in the hospital
Secondary	Heart rate	Heart rate [beats per minute] will be collected using the research prototype on the foot	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
Secondary	SpO2	Oxygen saturation (SpO2) will be collected using the research prototype on the foot	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