Protocol Number: 06-C-0118

Title:

A Study Evaluating the Agreement of Devices for Measuring Temperature in Children

Number:

06-C-0118

Summary:

Background:

-The accurate measurement of temperatures in children is essential to making appropriate clinical decisions.

-Oral, ear, and temporal artery thermometers (operated by swiping the device across the forehead) are all used at the NIH Clinical Center to measure temperatures in children.

-It is not known if the various devices for measuring temperature provide readings that are in agreement.

Objectives:

-To determine whether the ear thermometer, oral thermometer and temporal artery thermometer provide the same temperature readings and can be used interchangeably.

Eligibility:

-Children ages 4-17 admitted to the inpatient or day hospital of the NIH Clinical Center.

Design:

-This study will record temperatures in 32 children for no more than three episodes, with or without fever.

-During an episode without a fever, the child's temperature will be measured twice using all three devices.

-During an episode of fever, the child's temperature will be measured twice using all three devices at the following times: at the onset of fever, 2 hours after fever-reducing medication has been given, and 4 hours after the medication has been given.

-At each episode of recording temperatures, a questionnaire will be completed documenting fever status, patient symptoms, prior use of corticosteroids or fever-reducing medication (antipyretic) or pain medications that contain antipyretic.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: Yes

Population Exclusion(s): None

Eligibility Criteria:

INCLUSION CRITERIA:

1. Pediatric patients greater than or equal to 4 and less than or equal to 17 years of age seen at the Mark O. Hatfield Clinical Research Center.

2. Able to hold an oral thermometer in their mouth.

3. Informed consent: All patients or their legal guardians must sign a document of informed consent indicating their understanding of the purpose of this study and the risks associated with participation. As age appropriate, patients will be included in discussions about this study and verbal assent will be obtained.

4. All patients will be previously enrolled in an IRB approved Clinical Center protocol.

EXCLUSION CRITERIA:

1. Patients with acute life threatening infection.

2. Patients with ENT (aural) abnormalities.

3. Patients with severe mucositis who may have difficulty holding an oral thermometer.

4. Pediatric patients enrolled on a behavioral health research study.

Special Instructions:

Currently Not Provided

Keywords:

Thermometer

Fever

Neutropenia

Pediatric

Febrile

Recruitment Keyword(s):

Temperature

Thermometer

Fever

Condition(s):

Fever

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Cancer Institute

Contact(s):

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
Phone: 1-888-NCI-1937
Fax: Not Listed
Electronic Address: ncicssc@mail.nih.gov

Citation(s):

Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307-10.

Dybwik K, Nielsen EW. [Infrared temporal thermometry]Tidsskr Nor Laegeforen. 2003 Nov 6;123(21):3025-6. Norwegian.

Greenes DS, Fleisher GR. When body temperature changes, does rectal temperature lag? J Pediatr. 2004 Jun;144(6):824-6.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Networks and Applications, CC.

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