TIMMY3 Thermometer for Fever

Recruiting at 4 trial locations

Overseen By Ashley Wagoner, Ph.D.

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Baxter Healthcare Corporation

Must not be taking: Antipyretics, Barbiturates, Antipsychotics

Disqualifiers: Anatomical abnormalities, Neutropenic, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

420 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you should not take antipyretics (like aspirin, acetaminophen, or ibuprofen) within 120 minutes before the study.

What data supports the effectiveness of the Timmy3 Module treatment for fever?

The pilot study on continuous temperature monitoring in pediatric patients showed that continuous monitoring detected fevers earlier than standard methods, suggesting that similar continuous monitoring treatments like Timmy3 Module could be effective in early fever detection. ^{1 2 3 4 5}

How does the TIMMY3 Thermometer for Fever differ from other fever treatments?

The TIMMY3 Thermometer for Fever is unique because it likely involves a novel method of temperature measurement, potentially improving accuracy or ease of use compared to traditional thermometers like mercury or digital ones. While specific details about TIMMY3 are not provided, similar thermometers like Tempa-DOT and FeverScan have been studied for their accuracy in detecting fever, with Tempa-DOT showing a higher predictive value. ^{5 6 7 8 9}

What is the purpose of this trial?

The purpose of this document is to validate the clinical accuracy of the TIMMY3 thermometry module, integrated into host device CVSM, according to ISO 80601-2-56:2017 + A1 2018.

Research Team

Eric Fernandez, M.D.

Principal Investigator

Baxter Healthcare Corporation

Eligibility Criteria

This trial is for individuals from newborns to adults, specifically those aged 7-17 must agree to participate. Participants or their guardians must understand English, consent to the study's procedures, and be calm and cooperative. They should also have been in a stable room temperature for at least 20 minutes before having their temperature taken.

Inclusion Criteria

I am a full-term newborn, child, or adult.

The study subject is able to have their temperature taken for up to six minutes for multiple rounds of temperatures per anatomical site

Subject must be willing and able to comply with the study procedures

Exclusion Criteria

The study subject has any known contraindication to oral, axillary, or rectal temperature measurements

The study subject has consumed food or drink, or smoked, within the last 20 minutes. The subject may be included if they wait 20 minutes prior to taking oral temperature

The study subject has engaged in strenuous or semi-strenuous activity within the last twenty minutes (i.e., running, weightlifting, etc.)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Testing

Testing of the TIMMY3 thermometry module for clinical accuracy using SureTemp Plus algorithms

Up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after testing

4 weeks

Treatment Details

Interventions

• Timmy3 Module

Trial Overview The trial is testing the accuracy of the TIMMY3 thermometry module when used with the Connex CSVM device. It aims to ensure that this method of measuring body temperature meets international standards (ISO 80601-2-56:2017 + A1 2018).

Participant Groups

Group I: Rectal Temperature Measurement Experimental Treatment 1 Intervention

Rectal temperature measurements for all age groups (newborn to subjects older than 18 years of age) with no restrictions. Both febrile and non-febrile subjects included in this arm.

Group II: Oral Temperature Measurement Experimental Treatment 1 Intervention

Oral temperature measurements for subjects age Group C as 5 years or older. Both febrile and non-febrile subjects included in this arm.

Group III: Axillary Temperature Measurement Experimental Treatment 1 Intervention

Adult Axillary temperature measurement supports age Group C where C contains 18 years and older subjects. Pediatric Axillary temperature measurement supports newborn to 5 years and less than 18 years old. Both febrile and non-febrile subjects included in this arm.

Who Is Running the Clinical Trial?

Baxter Healthcare Corporation

Lead Sponsor

Trials

328

Recruited

203,000+

Dr. Heather Knight

Baxter Healthcare Corporation

Chief Medical Officer

MD

Brent Shafer

Baxter Healthcare Corporation

Chief Executive Officer

Bachelor's degree in Business Administration

Findings from Research

Continuous temperature monitoring using the TempTraq patch in a pilot study of 10 pediatric patients showed improved fever detection compared to standard episodic monitoring, identifying fevers that were missed or delayed by over 12 hours.

Caregivers found the TempTraq patch to be tolerable and easy to apply, suggesting it could be a practical tool for monitoring fever in immunocompromised patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of continuous temperature monitoring in pediatric immunocompromised patients: A pilot study. Sampson, M., Hickey, V., Huber, J., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Feasibility of continuous temperature monitoring in pediatric immunocompromised patients: A pilot study. [2019]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Fever and fever management among intensive care patients with known or suspected infection: a multicentre prospective cohort study. [2013]

3. United States pubmed.ncbi.nlm.nih.gov

In a systematic review, infrared ear thermometry for fever diagnosis in children finds poor sensitivity. [2018]

4. Italy pubmed.ncbi.nlm.nih.gov

A current analysis of caregivers' approaches to fever and antipyretic usage. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Performance of a non-contact infrared thermometer in healthy newborns. [2019]

6. Ireland pubmed.ncbi.nlm.nih.gov

The relative accuracy of mercury, Tempa-DOT and FeverScan thermometers. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

A comparison of temperature-taking methods in neonates. [2006]

8. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Medical digital thermometer]. [2006]

9. Netherlands pubmed.ncbi.nlm.nih.gov

[The ear thermometer; not a good replacement for the rectal thermometer]. [2006]