Temporal Artery Temperature Measurement in Neonates

Completed

• Conditions: Newborn Infant

• Registration Number: NCT02405429
• Lead Sponsor: University of Iowa

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Study First Submitted: 2015-03-25
• Study First Submitted QC: 2015-03-27
• Study First Posted: 2015-04-01
• Results First Submitted: 2017-03-07
• Results First Submitted QC: 2017-03-07
• Results First Posted: 2017-04-20
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-15
• Last Update Posted: 2017-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Temporal Artery Temperature	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
Axillary Temperature	Single measurement within 2 minutes of temporal artery and rectal temperature measurements	With commercial digital thermometer
Rectal Temperature	Single measurement within 2 minutes of temporal artery and axillary temperature measurements	With thermistor probe and telethermometer
Difference Between Temporal Artery and Rectal Temperatures	Within 2 minutes of each other	Rectal temperature minus temporal artery temperature
Difference Between Rectal and Axillary Temperatures	Within 2 minutes of each other	Rectal temperature minus axillary temperature