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

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.

Study Overview

• Status: Suspended
• Conditions: Fever
• Intervention / Treatment: Other: Unobtrusive data collection using wearable non-invasive sensors

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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Saint Gallen, Switzerland, 9000
    • Children's Hospital of Eastern Switzerland, St. Gallen
  • Zurich, Switzerland, 8000
    • University Children's Hospital Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 weeks to 1 year (Child)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Unobtrusive data collection	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..

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: greenTEG AG
• Collaborators: University Children's Hospital, Zurich; Children's Hospital of Eastern Switzerland, St. Gallen
• Investigators: Principal Investigator: Christoph Berger, Prof. Dr., University Children's Hospital, Zurich

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2020
• Primary Completion (Estimated): March 30, 2025
• Study Completion (Estimated): March 30, 2025

Study Registration Dates

• First Submitted: November 26, 2020
• First Submitted That Met QC Criteria: December 3, 2020
• First Posted (Actual): December 4, 2020

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: fever; wearable; core body temperature
• Additional Relevant MeSH Terms: Body Temperature Changes; Fever
• Other Study ID Numbers: 6058_Baby_study_1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The results of this study will be published in a suited journal. Publication strategy is still in discussion.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No