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

This study has been completed.
Sponsor:
Information provided by:
Christiana Care Health Services
ClinicalTrials.gov Identifier:
NCT00762489
First received: September 29, 2008
Last updated: April 28, 2011
Last verified: April 2011
  Purpose

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.


Condition Intervention
Newborn Infants
Other: Temporal artery thermometer temperature

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Official Title: Comparison of Temporal Artery, Axillary, and Rectal Temperatures in Newborn Patients in the Well Baby Nursery.

Further study details as provided by Christiana Care Health Services:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 104
Study Start Date: October 2008
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
TAT vs. RT
This arm is comparing the Temporal Artery Thermometer (TAT) temperature to the Rectal Temperature (RT).
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.
Other Name: Exergen TAT-5000 TemporalScanner Exergen Corp; Watertown, MA)
TAT vs. AT
This arm is comparing the Temporal Artery Thermometer (TAT) temperature to the Axillary Temperature (AT).
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.
Other Name: Exergen TAT-5000 TemporalScanner Exergen Corp; Watertown, MA)

  Eligibility

Ages Eligible for Study:   up to 24 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00762489

Locations
United States, Delaware
Christiana Care Health Systems
Newark, Delaware, United States, 19713
Sponsors and Collaborators
Christiana Care Health Services
Investigators
Principal Investigator: Michael F. Bruno, MD Christiana Care Health Services
  More Information

No publications provided

Responsible Party: Michael F. Bruno, MD, Christiana Care Health Systems
ClinicalTrials.gov Identifier: NCT00762489     History of Changes
Other Study ID Numbers: 28148
Study First Received: September 29, 2008
Last Updated: April 28, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Christiana Care Health Services:
Temporal artery thermometry
Rectal temperature
Axillary temperature
Newborns
Temperature measurement

ClinicalTrials.gov processed this record on August 28, 2014