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

March 14, 2012 updated by: National Institutes of Health Clinical Center (CC)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892-1182
        • Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 17 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Similarities or differences in the percent of fevers detected with oral, ear, and temporal artery monitoring
Differences in agreement of the various temperature devices

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institutes of Health Clinical Center (CC)

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Study Completion (ACTUAL)

November 1, 2009

Study Registration Dates

First Submitted

September 19, 2006

First Submitted That Met QC Criteria

September 19, 2006

First Posted (ESTIMATE)

September 21, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

March 15, 2012

Last Update Submitted That Met QC Criteria

March 14, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 060118
  • 06-C-0118
  • NCI-P6842
  • CDR0000496917

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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