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Active, not recruitingNCT06556628Updated Aug 16, 2024

Tympanic Thermometer Study

An observational study in Body Temperature Changes and Fever, sponsored by Baxter Healthcare Corporation. Active, not recruiting at 1 site in United States. Per ClinicalTrials.gov, last updated 2024-08-16.

Primary conditionFeverRegistry: Body Temperature ChangesReclassifiedWhy we changed it
Registry
Body Temperature Changes — the first condition term the registry derived for this study.
ClinicalTrials.gg
Fever
Why
  1. The study's listed conditions name Fever, a narrower term within Body Temperature Changes.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Baxter Healthcare Corporation · Observational

From the registry’s dates

  • Primary completion was expected by May 2025, 1 year 5 months ago, but the record still lists the study as active, not recruiting.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
1,000
Sex
All
01

Study summary

The goal of this study is to collect febrile, healthy, and in some instances cold temperature data from human subjects ranging from newborns to geriatrics. This data will be used to develop a new thermometer.

02

Conditions studied

  • Body Temperature Changes
  • Fever

Browse trials for

03

In context

Fever Reclassified

438 studies on the registry are indexed under Fever; 55 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 408 across 140 observational studies indexed under Fever.

Browse Fever studies →

Lead sponsor

Baxter Healthcare Corporation is the lead sponsor of 80 studies on the registry; 1 is open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 3 (30%) have results posted.

Browse Baxter Healthcare Corporation studies →

Compared within Fever, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Body Temperature Changes. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Subjects recruited to participate in this study may range in age from normal weight (≥2.5kg), full-term (37 weeks gestation) newborns to geriatric adults. The subject may be anyone who is willing to have their temperature taken who also meets the eligibility criteria. Study subjects may have normal, febrile, or cold temperatures.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age: normal weight (≥2.5kg), full-term (37 weeks gestation) newborn to geriatric adult.
  • Participant, legal guardian, or healthcare proxy is able to give consent to participate.
  • Participant, legal guardian, or healthcare proxy speaks fluent English.

Exclusion criteria

Exclusion Criteria:

  • The subject does not meet the inclusion criteria.
  • The subject has anatomical abnormalities that would affect temperature.
  • The subject has blood or drainage in the external ear canal.
  • The subject has had something in their ear for a prolonged period, such as a hearing aid or headphones. The subject may be included if the hearing aid or headphones are removed at least 30 minutes prior to taking ear temperature.
  • The subject has been lying on ear within 30 minutes of data collection. The subject may be included if they wait 30 minutes prior to having an ear temperature measurement taken.
  • The subject exhibits symptoms of an acute or chronic inflammatory condition of the external ear canal. An example would be swimmer's ear. The subject may be included if the acute or chronic inflammatory condition is isolated to one ear, then the other ear may be used for data collection.
  • The subject has an ear obstruction or excess cerumen build-up.
  • The subject is in acute distress, i.e., severe pain, severe emotional distress or agitation that would inhibit them from participating in a tympanic ear temperature study.
  • The subject has any known to oral, ear, or axillary temperature measurements.
  • The subject has used ear drops in the last 8 hours. The subject may be included if the other ear was not medicated with ear drops in the last 8 hours.
  • The subject (age 5+) 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 subject has taken an antipyretic (ex: Tylenol, Motrin, Aspirin) in the last 120 minutes.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
1,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • Fever

    Elevated oral temperature of 37.5C or higher or elevated axillary temperature of 37.2C or higher.

    Device: Increased Body Temperatures

  • Healthy

    Oral temperature between 36-37.4C Axillary temperature between 36-37.1C

  • Cold

    Oral or axillary temperatures below 36C

Interventions

  • DeviceIncreased Body Temperatures

    Collecting data on patients whose body temperatures increase due to fighting an illness.

06

What researchers measure

Primary outcomes

  1. Clinical Bias

    The mean difference between output temperatures of the clinical thermometer under test

    Time frame: Immediately after the diagnostic test

Secondary outcomes

  1. Repeatability

    Pooled standard deviation (over a selected group of subjects) of changes in multiple output temperatures taken from the same subject at the same measuring site with the same clinical thermometer by the same operator within a relatively short time

    Time frame: Immediately after the diagnostic test

  2. Limits of Agreement

    The magnitude of a potential disagreement between outputs of two clinical thermometers equal to double the standard deviation of output temperature differences when used on the same human subject.

    Time frame: Immediately after the diagnostic test

07

Study locations

1 site
  • Baxter
    Skaneateles, New York 13153, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Apr 2022 (actual). Primary completion is estimated for May 2025, 37 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 12, 2024
First posted
Aug 16, 2024
StartActual
Apr 11, 2022
Primary completionEst.
May 31, 2025
CompletionEst.
May 31, 2025
Last update
Aug 16, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06556628
Lead sponsor
Baxter Healthcare Corporation
Responsible party
Sponsor
First posted
Aug 16, 2024
Start date
Apr 11, 2022
Primary completion
May 31, 2025 (estimated)
Completion
May 31, 2025 (estimated)
Last update
Aug 16, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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