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

Primary Purpose

Fever, Sweats, and Hot Flashes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
infrared thermography
Sponsored by
National Institutes of Health Clinical Center (CC)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Fever, Sweats, and Hot Flashes focused on measuring fever, sweats, and hot flashes

Eligibility Criteria

4 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

Outcomes

Primary Outcome Measures

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

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

Full Information

First Posted
September 19, 2006
Last Updated
March 14, 2012
Sponsor
National Institutes of Health Clinical Center (CC)
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00378846
Brief Title
Three Different Types of Thermometers in Measuring Temperature in Young Patients With Fever and Without Fever
Official Title
A Study Evaluating the Agreement of Devices for Measuring Temperature in Children
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institutes of Health Clinical Center (CC)
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fever, Sweats, and Hot Flashes
Keywords
fever, sweats, and hot flashes

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
infrared thermography
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Similarities or differences in the percent of fevers detected with oral, ear, and temporal artery monitoring
Title
Differences in agreement of the various temperature devices

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas J. Walsh, MD
Organizational Affiliation
National Cancer Institute (NCI)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892-1182
Country
United States

12. IPD Sharing Statement

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

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