Temporal Artery Temperature Measurement in Neonates

May 15, 2017 updated by: Edward F. Bell, University of Iowa

Comparing Temporal Artery and Axillary Temperatures With Rectal Temperature in Neonates

The aim of this study was to evaluate the temporal artery thermometer by comparing temporal artery and axillary thermometer temperature measurements with rectal thermometer temperature measurements in neonatal patients. The investigators measured temporal artery, axillary, and rectal temperatures of 49 infants. Temporal artery temperature was measured using an infrared temporal artery thermometer, and the results with this device were compared with axillary temperature (clinical standard) and rectal temperature (gold standard). The difference between rectal and temporal artery temperatures was compared with the difference between rectal and axillary temperatures for each infant, and the data were analyzed based on weight, postmenstrual age and bed type - open crib or incubator.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

49

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 6 months (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hospital nursery patients

Description

Inclusion Criteria:

  • Patients in hospital well-baby nursery or neonatal intensive care unit

Exclusion Criteria:

  • Birth weight <500 grams
  • Anal atresia
  • Central nervous system malformation
  • Hypoxic-ischemic encephalopathy
  • Clinical concerns for necrotizing enterocolitis or other bowel injury or discontinuity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Temporal Artery Temperature
Time Frame: Mean of 2 measurements within 2 minutes of each other and within 2 minutes of axillary and rectal temperature measurements
With commercial infrared temporal artery thermometer
Mean of 2 measurements within 2 minutes of each other and within 2 minutes of axillary and rectal temperature measurements
Axillary Temperature
Time Frame: Single measurement within 2 minutes of temporal artery and rectal temperature measurements
With commercial digital thermometer
Single measurement within 2 minutes of temporal artery and rectal temperature measurements
Rectal Temperature
Time Frame: Single measurement within 2 minutes of temporal artery and axillary temperature measurements
With thermistor probe and telethermometer
Single measurement within 2 minutes of temporal artery and axillary temperature measurements
Difference Between Temporal Artery and Rectal Temperatures
Time Frame: Within 2 minutes of each other
Rectal temperature minus temporal artery temperature
Within 2 minutes of each other
Difference Between Rectal and Axillary Temperatures
Time Frame: Within 2 minutes of each other
Rectal temperature minus axillary temperature
Within 2 minutes of each other

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Iowa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (ACTUAL)

August 1, 2014

Study Completion (ACTUAL)

August 1, 2014

Study Registration Dates

First Submitted

March 25, 2015

First Submitted That Met QC Criteria

March 27, 2015

First Posted (ESTIMATE)

April 1, 2015

Study Record Updates

Last Update Posted (ACTUAL)

June 14, 2017

Last Update Submitted That Met QC Criteria

May 15, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 201404832

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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