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

NCT04654559 | Suspended

• 1 other identifier: 6058_Baby_study_1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Fever

Keywords

core body temperature; fever; wearable

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (2)

• Heart rate

  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

  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

Study Arms (1)

Unobtrusive data collection

OTHER

Other: Unobtrusive data collection using wearable non-invasive sensors

Interventions

Unobtrusive data collection using wearable non-invasive sensors OTHER

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..

Unobtrusive data collection

Eligibility Criteria

• Age: 2 Weeks - 18 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• greenTEG AG: lead
• University Children's Hospital, Zurich: collaborator
• Department of Child Development, Children's Hospital St. Gallen, Switzerland: collaborator

Study Sites (2)

Children's Hospital of Eastern Switzerland, St. Gallen

Sankt Gallen, 9000, Switzerland

Location

University Children's Hospital Zurich

Zurich, 8000, Switzerland

Location

MeSH Terms

Conditions

Fever

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Christoph Berger, Prof. Dr.

  University Children's Hospital, Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2020
• First Posted: December 4, 2020
• Study Start: April 7, 2020
• Primary Completion: March 30, 2025
• Study Completion: March 30, 2025
• Last Updated: March 15, 2024

Record last verified: 2024-03

Locations

CH (2)