Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Temporal Artery Temperature Measurement in Neonates

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: NCT02405429
Recruitment Status : Completed
First Posted : April 1, 2015
Results First Posted : April 20, 2017
Last Update Posted : June 14, 2017
Sponsor:
Information provided by (Responsible Party):
Edward F. Bell, University of Iowa

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The aim of this study was to evaluate the temporal artery thermometer by comparing temporal artery and axillary thermometer temperature measurements with rectal thermometer temperature measurements in neonatal patients. The investigators measured temporal artery, axillary, and rectal temperatures of 49 infants. Temporal artery temperature was measured using an infrared temporal artery thermometer, and the results with this device were compared with axillary temperature (clinical standard) and rectal temperature (gold standard). The difference between rectal and temporal artery temperatures was compared with the difference between rectal and axillary temperatures for each infant, and the data were analyzed based on weight, postmenstrual age and bed type - open crib or incubator.

Condition or disease
Newborn Infant

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 49 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Comparing Temporal Artery and Axillary Temperatures With Rectal Temperature in Neonates
Study Start Date : May 2014
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Temporal Artery Temperature [ Time Frame: Mean of 2 measurements within 2 minutes of each other and within 2 minutes of axillary and rectal temperature measurements ]
    With commercial infrared temporal artery thermometer

  2. Axillary Temperature [ Time Frame: Single measurement within 2 minutes of temporal artery and rectal temperature measurements ]
    With commercial digital thermometer

  3. Rectal Temperature [ Time Frame: Single measurement within 2 minutes of temporal artery and axillary temperature measurements ]
    With thermistor probe and telethermometer

  4. Difference Between Temporal Artery and Rectal Temperatures [ Time Frame: Within 2 minutes of each other ]
    Rectal temperature minus temporal artery temperature

  5. Difference Between Rectal and Axillary Temperatures [ Time Frame: Within 2 minutes of each other ]
    Rectal temperature minus axillary temperature


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Hospital nursery patients
Criteria

Inclusion Criteria:

  • Patients in hospital well-baby nursery or neonatal intensive care unit

Exclusion Criteria:

  • Birth weight <500 grams
  • Anal atresia
  • Central nervous system malformation
  • Hypoxic-ischemic encephalopathy
  • Clinical concerns for necrotizing enterocolitis or other bowel injury or discontinuity
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02405429


Sponsors and Collaborators
University of Iowa
Investigators
Layout table for investigator information
Principal Investigator: Edward F Bell, MD University of Iowa
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

Layout table for additonal information
Responsible Party: Edward F. Bell, Professor of Pediatrics, University of Iowa
ClinicalTrials.gov Identifier: NCT02405429    
Other Study ID Numbers: 201404832
First Posted: April 1, 2015    Key Record Dates
Results First Posted: April 20, 2017
Last Update Posted: June 14, 2017
Last Verified: May 2017