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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00378846
First received: September 19, 2006
Last updated: March 14, 2012
Last verified: March 2012
  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
Fever, Sweats, and Hot Flashes
Procedure: infrared thermography

Study Type: Interventional
Study Design: Primary Purpose: Diagnostic
Official Title: A Study Evaluating the Agreement of Devices for Measuring Temperature in Children

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

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
Study Completion Date: November 2009
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Bethesda, Maryland, United States, 20892-1182
Sponsors and Collaborators
Investigators
Principal Investigator: Thomas J. Walsh, MD National Cancer Institute (NCI)
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00378846     History of Changes
Other Study ID Numbers: 060118, 06-C-0118, NCI-P6842, CDR0000496917
Study First Received: September 19, 2006
Last Updated: March 14, 2012
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on July 23, 2014