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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00762489
Recruitment Status : Completed
First Posted : September 30, 2008
Last Update Posted : April 29, 2011
Sponsor:
Information provided by:
Christiana Care Health Services

Tracking Information
First Submitted Date  ICMJE September 29, 2008
First Posted Date  ICMJE September 30, 2008
Last Update Posted Date April 29, 2011
Study Start Date  ICMJE October 2008
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 29, 2008)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Three Methods of Taking Temperatures in the Well Baby Nursery
Official Title  ICMJE Comparison of Temporal Artery, Axillary, and Rectal Temperatures in Newborn Patients in the Well Baby Nursery.
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Condition  ICMJE Newborn Infants
Intervention  ICMJE 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)
Study Arms  ICMJE
  • TAT vs. RT
    This arm is comparing the Temporal Artery Thermometer (TAT) temperature to the Rectal Temperature (RT).
    Intervention: Other: Temporal artery thermometer temperature
  • TAT vs. AT
    This arm is comparing the Temporal Artery Thermometer (TAT) temperature to the Axillary Temperature (AT).
    Intervention: Other: Temporal artery thermometer temperature
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 28, 2011)
104
Original Estimated Enrollment  ICMJE
 (submitted: September 29, 2008)
200
Actual Study Completion Date  ICMJE August 2009
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 24 Hours   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00762489
Other Study ID Numbers  ICMJE 28148
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Michael F. Bruno, MD, Christiana Care Health Systems
Study Sponsor  ICMJE Christiana Care Health Services
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael F. Bruno, MD Christiana Care Health Services
PRS Account Christiana Care Health Services
Verification Date April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP