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Three Different Types of Thermometers in Measuring Temperature in Young Patients With Fever and Without Fever

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ClinicalTrials.gov Identifier: NCT00378846
Recruitment Status : Completed
First Posted : September 21, 2006
Last Update Posted : March 15, 2012
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief 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.

PURPOSE: This clinical trial is studying three different types of thermometers to measure temperature in young patients with fever and without fever.


Condition or disease Intervention/treatment
Fever, Sweats, and Hot Flashes Procedure: infrared thermography

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Primary Purpose: Diagnostic
Official Title: A Study Evaluating the Agreement of Devices for Measuring Temperature in Children
Study Start Date : March 2006
Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever Sweat
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Similarities or differences in the percent of fevers detected with oral, ear, and temporal artery monitoring
  2. Differences in agreement of the various temperature devices

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00378846


Locations
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, United States, 20892-1182
Sponsors and Collaborators
National Institutes of Health Clinical Center (CC)
National Cancer Institute (NCI)
Investigators
Principal Investigator: Thomas J. Walsh, MD National Cancer Institute (NCI)
More Information

ClinicalTrials.gov Identifier: NCT00378846     History of Changes
Other Study ID Numbers: 060118
06-C-0118
NCI-P6842
CDR0000496917
First Posted: September 21, 2006    Key Record Dates
Last Update Posted: March 15, 2012
Last Verified: March 2012

Keywords provided by National Institutes of Health Clinical Center (CC):
fever, sweats, and hot flashes

Additional relevant MeSH terms:
Fever
Hot Flashes
Body Temperature Changes
Signs and Symptoms