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

Not Applicable

Completed

• Conditions: Newborn Infants
• Interventions: Other: Temporal artery thermometer temperature

• Registration Number: NCT00762489
• Lead Sponsor: Christiana Care Health Services

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-09-29
• Study First Submitted QC: 2008-09-29
• Study First Posted: 2008-09-30
• Study Start: 2008-10
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-28
• Last Update Posted: 2011-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TAT vs. RT	Temporal artery thermometer temperature	This arm is comparing the Temporal Artery Thermometer (TAT) temperature to the Rectal Temperature (RT).
TAT vs. AT	Temporal artery thermometer temperature	This arm is comparing the Temporal Artery Thermometer (TAT) temperature to the Axillary Temperature (AT).

Primary Outcome Measures

Name	Time	Method
Accuracy of temporal artery temperature compared to rectal and axillary temperature measurements.	All temperatures will be taken within 5 minutes of each other

Trial Locations

Locations (1)

Christiana Care Health Systems; 🇺🇸 Newark, Delaware, United States