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OpenTrials
Completed

NCT Number: NCT00762489

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

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.

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Key information

Conditions

Age range

Up to 24 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Christiana Care Health Systems

Newark, Delaware, 19713, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Temporal artery thermometer temperature

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.

Other names: Exergen TAT-5000 TemporalScanner Exergen Corp; Watertown, MA)

Primary outcomes

  1. Accuracy of temporal artery temperature compared to rectal and axillary temperature measurements.

    Time frame: All temperatures will be taken within 5 minutes of each other

Sponsors and collaborators

Lead sponsor

Christiana Care Health Services

Other

Registry information

Official study title

Comparison of Temporal Artery, Axillary, and Rectal Temperatures in Newborn Patients in the Well Baby Nursery.

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Sep 30, 2008
Registry last updated
Apr 29, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.