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Comparison of Three Methods of Taking Temperatures in the Well Baby Nursery

NCT ID: NCT00762489

Last Updated: 2011-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2009-08-31

Brief Summary

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Body temperature measurement is one of the standard vital sign measurements in newborn babies in order assess their health status. Temperatures are taken on a regular basis throughout the newborn's stay on the well-baby floor. A temperature that is elevated above the normal range for age or depressed below the normal range for age may be a sign of illness in a newborn. There are many methods that may be used to record this temperature. Traditionally, axillary (under the arm) and rectal (in the rectum) sites have been used. Recently, a new method of temperature measurement has become available. Temporal artery thermometers are a non-invasive method to measure the baby's temperature by means of a light that is shone on the forehead that can read your baby's temperature quickly. It is not clear whether this method is accurate in the newborn period.

The purpose of this study is to evaluate the accuracy of temporal artery temperature measurement. This will be achieved by observing the axillary measurement, rectal temperature measurement, and temporal artery temperature measurement taken at approximately the same time in each infant. These measurements will be compared to each other to determine if temporal artery thermometry is as reliable a measurement as rectal and / or axillary temperature measurements.

We plan to compare

Hypothesis: Temporal artery thermometry of the immediate newborn infant is an accurate measurement of temperature in this age group.

Detailed Description

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Conditions

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Newborn Infants

Keywords

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Temporal artery thermometry Rectal temperature Axillary temperature Newborns Temperature measurement

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Study Groups

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TAT vs. RT

This arm is comparing the Temporal Artery Thermometer (TAT) temperature to the Rectal Temperature (RT).

Group Type OTHER

Temporal artery thermometer temperature

Intervention Type OTHER

Newborn infants had a temporal artery temperature taken within a few minutes of the axillary and rectal temperatures. The axillary and rectal temperatures are taken via methods which are standard of care.

TAT vs. AT

This arm is comparing the Temporal Artery Thermometer (TAT) temperature to the Axillary Temperature (AT).

Group Type OTHER

Temporal artery thermometer temperature

Intervention Type OTHER

Newborn infants had a temporal artery temperature taken within a few minutes of the axillary and rectal temperatures. The axillary and rectal temperatures are taken via methods which are standard of care.

Interventions

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Temporal artery thermometer temperature

Newborn infants had a temporal artery temperature taken within a few minutes of the axillary and rectal temperatures. The axillary and rectal temperatures are taken via methods which are standard of care.

Intervention Type OTHER

Other Intervention Names

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Exergen TAT-5000 TemporalScanner Exergen Corp; Watertown, MA)

Eligibility Criteria

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Inclusion Criteria

* term newborns \>/= 37 weeks gestational age
* late preterm infants \>/= 35 weeks gestational age
* admitted to the well baby nursery following delivery
* \< 24 hours of age

Exclusion Criteria

* Infants \< 35 weeks gestational age
* Infants currently under a radiant warmer or who have been under a radiant warmer \< 1 hour prior to temperature measurement.
Maximum Eligible Age

24 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Christiana Care Health Services

OTHER

Sponsor Role lead

Responsible Party

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Christiana Care Health Systems

Principal Investigators

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Michael F. Bruno, MD

Role: PRINCIPAL_INVESTIGATOR

Christiana Care Health Services

Locations

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Christiana Care Health Systems

Newark, Delaware, United States

Site Status

Countries

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United States

Other Identifiers

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28148

Identifier Type: -

Identifier Source: org_study_id