Three Different Types of Thermometers in Measuring Temperature in Young Patients With Fever and Without Fever - Full Text View

Sponsor:	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
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:

MedlinePlus related topics: Fever Sweat

U.S. FDA Resources

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
Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

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
Bethesda, Maryland, United States, 20892-1182

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Thomas J. Walsh, MD

NCI - Pediatric Oncology Branch

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00378846 History of Changes
Other Study ID Numbers:	CDR0000496917, NCI-06-C-0118, NCI-P6842
Study First Received:	September 19, 2006
Last Updated:	November 26, 2009
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

fever, sweats, and hot flashes

Additional relevant MeSH terms:

Fever
Hot Flashes
Body Temperature Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on February 09, 2012