Temporal Artery Temperature Measurement in Neonates

NCT02405429 | Completed Results

• 1 other identifier: 201404832
• Study Type: observational
• Target: 49
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Newborn Infant

Outcome Measures

Primary Outcomes (5)

• Temporal Artery Temperature

  With commercial infrared temporal artery thermometer

  Mean of 2 measurements within 2 minutes of each other and within 2 minutes of axillary and rectal temperature measurements

• Axillary Temperature

  With commercial digital thermometer

  Single measurement within 2 minutes of temporal artery and rectal temperature measurements

• Rectal Temperature

  With thermistor probe and telethermometer

  Single measurement within 2 minutes of temporal artery and axillary temperature measurements

• Difference Between Temporal Artery and Rectal Temperatures

  Rectal temperature minus temporal artery temperature

  Within 2 minutes of each other

• Difference Between Rectal and Axillary Temperatures

  Rectal temperature minus axillary temperature

  Within 2 minutes of each other

Eligibility Criteria

• Age: Up to 6 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Hospital nursery patients

You may qualify if:

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

You may not qualify if:

• Birth weight \<500 grams
• Anal atresia
• Central nervous system malformation
• Hypoxic-ischemic encephalopathy
• Clinical concerns for necrotizing enterocolitis or other bowel injury or discontinuity

Sponsors & Collaborators

• University of Iowa: lead

Related Publications (1)

• Syrkin-Nikolau ME, Johnson KJ, Colaizy TT, Schrock R, Bell EF. Temporal Artery Temperature Measurement in the Neonate. Am J Perinatol. 2017 Aug;34(10):1026-1031. doi: 10.1055/s-0037-1601440. Epub 2017 Apr 10.

  PMID: 28395367 RESULT

Results Point of Contact

• Title: Edward F. Bell, MD
• Organization: University of Iowa

edward-bell@uiowa.edu

319-356-4006

Study Officials

• Edward F Bell, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: March 25, 2015
• First Posted: April 1, 2015
• Study Start: May 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: June 14, 2017
• Results First Posted: April 20, 2017

Record last verified: 2017-05