Fever, Sweats, and Hot FlashesNCT00378846
Three Different Types of Thermometers in Measuring Temperature in Young Patients With Fever and Without Fever
A study testing infrared thermography in people with Fever, Sweats, and Hot Flashes, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial summary
RATIONALE: Comparing results of three different thermometers used to measure body temperature may help doctors find the most accurate thermometer to detect fever and plan the best treatment. Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Fever, Sweats, and Hot Flashes
- What is being tested?
- infrared thermography
- Type of treatment
- Surgery or procedure
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Nov 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 17 years
- All sexes
- No healthy volunteers
- Child
DISEASE CHARACTERISTICS:
- Febrile or afebrile
- Patient at the Mark O. Harfield Clinical Research Center
- Previously enrolled in an IRB-approved Clinical Center protocol
PATIENT CHARACTERISTICS:
- Able to hold an oral thermometer in mouth
- No acute life-threatening infection
- No ear, nose, or throat (aural) abnormalities
- No severe mucositis
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No concurrent enrollment on a behavioral research study
Trial locations and contacts
1 site in 1 country.
United States1 site
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, 20892-1182
About this study
Official title: A Study Evaluating the Agreement of Devices for Measuring Temperature in Children
RATIONALE: Comparing results of three different thermometers used to measure body temperature may help doctors find the most accurate thermometer to detect fever and plan the best treatment.
PURPOSE: This clinical trial is studying three different types of thermometers to measure temperature in young patients with fever and without fever.
Read the detailed description
OBJECTIVES:
Primary
- Determine agreement between three different types of temperature-measuring instruments: the temporal artery scanner, the digital oral thermometer, and the infrared tympanic thermometer calibrated to an oral setting, in pediatric patients who are febrile and afebrile.
Secondary
- Determine similarities or differences in the percent of fevers detected with oral, ear, and temporal artery monitoring in these pediatric patients.
- Determine differences in agreement of the various temperature devices in non-neutropenic pediatric patients versus neutropenic pediatric patients.
OUTLINE: This is a prospective study.
During an afebrile episode, the patient's temperature is measured twice using the following 3 devices: a temporal artery scanner, a digital oral thermometer, and an infrared tympanic thermometer calibrated to an oral setting (total of 6 temperature measurements per afebrile episode).
During a febrile episode, the patient's temperature is measured twice using all 3 devices as above, and then at 2 and 4 hours after administration of an antipyretic medication (total of 18 temperatures per febrile episode).
Patients' temperatures are recorded for a maximum of 3 afebrile or febrile episodes.
PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study.
- Conditions
- Fever, Sweats, and Hot Flashes
- Being tested
- infrared thermography
- Keywords
- fever, sweats, and hot flashes
- Medical subject headings
- Fever, Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
infrared thermographyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement between the temporal artery scanner, digital oral thermometer, and infrared tympanic thermometer calibrated to an oral setting in pediatric patients who are febrile and afebrile
Secondary outcomes (2)
Similarities or differences in the percent of fevers detected with oral, ear, and temporal artery monitoring
Differences in agreement of the various temperature devices
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2006 (estimated)
- Study startMar 2006
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fever, Sweats, and Hot FlashesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Thomas J. Walsh, MD, Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00378846
- Sponsor's protocol ID
- 060118
- Other IDs
- 06-C-0118, NCI-P6842, CDR0000496917
- Status last verified
- Mar 2012
- First submitted
- 19 Sep 2006
- Last updated
- 15 Mar 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Evaluating the Agreement of Devices for Measuring Temperature in Children
- ClinicalTrials.gov ID
- NCT00378846
- Acronym / sponsor ID
- 060118
- Conditions
- Fever, Sweats, and Hot Flashes
- Keywords
- fever, sweats, and hot flashes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2006
- Study completion
- Nov 2009 (actual)
- First posted
- 21 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Comparing results of three different thermometers used to measure body temperature may help doctors find the most accurate thermometer to detect fever and plan the best treatment.
PURPOSE: This clinical trial is studying three different types of thermometers to measure temperature in young patients with fever and without fever.
Detailed description
OBJECTIVES:
Primary
- Determine agreement between three different types of temperature-measuring instruments: the temporal artery scanner, the digital oral thermometer, and the infrared tympanic thermometer calibrated to an oral setting, in pediatric patients who are febrile and afebrile.
Secondary
- Determine similarities or differences in the percent of fevers detected with oral, ear, and temporal artery monitoring in these pediatric patients.
- Determine differences in agreement of the various temperature devices in non-neutropenic pediatric patients versus neutropenic pediatric patients.
OUTLINE: This is a prospective study.
During an afebrile episode, the patient's temperature is measured twice using the following 3 devices: a temporal artery scanner, a digital oral thermometer, and an infrared tympanic thermometer calibrated to an oral setting (total of 6 temperature measurements per afebrile episode).
During a febrile episode, the patient's temperature is measured twice using all 3 devices as above, and then at 2 and 4 hours after administration of an antipyretic medication (total of 18 temperatures per febrile episode).
Patients' temperatures are recorded for a maximum of 3 afebrile or febrile episodes.
PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study.
Study design
- Primary purpose
- Diagnosis
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| infrared thermography | Procedure or surgery | – |
Primary outcome
Agreement between the temporal artery scanner, digital oral thermometer, and infrared tympanic thermometer calibrated to an oral setting in pediatric patients who are febrile and afebrile
2 secondary outcomes
Similarities or differences in the percent of fevers detected with oral, ear, and temporal artery monitoring
Differences in agreement of the various temperature devices
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas J. Walsh, MD principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing infrared thermography in people with Fever, Sweats, and Hot Flashes, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement between the temporal artery scanner, digital oral thermometer, and infrared tympanic thermometer calibrated to an oral setting in pediatric patients who are febrile and afebrile. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2012.