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Three Different Types of Thermometers in Measuring Temperature in Young Patients With Fever and Without Fever
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), October 2007
First Received: September 19, 2006   Last Updated: February 6, 2009   History of Changes
Sponsored by: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00378846
  Purpose

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 Intervention
Cancer-Related Problem/Condition
Procedure: infrared thermography

MedlinePlus related topics: Fever
U.S. FDA Resources
Study Type: Interventional
Study Design: Diagnostic
Official Title: A Study Evaluating the Agreement of Devices for Measuring Temperature in Children

Further study details as provided by National Cancer Institute (NCI):

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 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Similarities or differences in the percent of fevers detected with oral, ear, and temporal artery monitoring [ Designated as safety issue: No ]
  • Differences in agreement of the various temperature devices [ Designated as safety issue: No ]

Estimated Enrollment: 32
Study Start Date: March 2006
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.

  Eligibility

Ages Eligible for Study:   4 Years to 17 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00378846

Locations
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office Recruiting
Bethesda, Maryland, United States, 20892-1182
Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center     888-NCI-1937        
Sponsors and Collaborators
Investigators
Principal Investigator: Thomas J. Walsh, MD NCI - Pediatric Oncology Branch
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000496917, NCI-06-C-0118, NCI-P6842
Study First Received: September 19, 2006
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00378846     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
fever, sweats, and hot flashes

Study placed in the following topic categories:
Fever
Hot Flashes

ClinicalTrials.gov processed this record on May 07, 2009