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

NCT00762489 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2011-04-29

No results posted yet for this study

Summary

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.

Conditions

  • Newborn Infants

Interventions

OTHER

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.

Sponsors & Collaborators

  • Christiana Care Health Services

    lead OTHER

Principal Investigators

  • Michael F. Bruno, MD · Christiana Care Health Services

Study Design

Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP

Eligibility

Max Age
24 Hours
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2009-08-31
Completion
2009-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00762489 on ClinicalTrials.gov