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

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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 ...

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. Endpoint(s): ST, HF, heartrate (HR), SpO2 and CBT data are collected for 18-72 hours, depending on the stationary stay of the patient. ST, HF, HR and CBT values from the different measurement positions (lateral ribcage and foot) of the wearable prototypes, will be compared with each other, and to the clinical invasive method. The invasive reference method will be rectal temperature assessed every 8 hours (clinical standard care). For infants older than 6 months, ear temperature will be assessed every 4 hours with an infrared ear thermometer. Study Design: Interventional-Single Group Assignment, monocentric, open label 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 2? (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. 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 Zürich for more than 1 day (in-patients) Informed consent signed by parents or by its legal representative 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) Number of Participants: 50 patients are planned to be included in this study. The reason to plan with 50 patients is that the data of 35 patients are needed to build/develop the fever detecting algorithm and the data of 15 additional patients will serve the purpose to validate and adjust the algorithm. Study Intervention: Two core body temperature sensing research prototypes will be applied to the skin of recruited patients. These prototypes will not interfere with clinical standard monitoring procedures and will measure inconspicuously without displaying any values. Furthermore, rectal temperature will be measured every 8 hours by medical staff using the clinically established method of the hospital. For infants older than 6 months, ear temperature will be assessed every 4 hours with an infrared ear thermometer. The measurement will be between 18-72 hours, depending on the stationary stay of the patient. Control Intervention: Not applicable 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.

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