Temporal Artery Temperature Measurement in Neonates

Newborn Infant Clinical Trial

Official title:

Comparing Temporal Artery and Axillary Temperatures With Rectal Temperature in Neonates

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02405429
• Other study ID #: 201404832
• Status: Completed
• Phase: N/A
• First received: March 25, 2015
• Last updated: March 27, 2015
• Start date: May 2014
• Est. completion date: August 2014

Study information

• Verified date: March 2015
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 6 Months

Eligibility

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

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Newborn Infant

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Iowa

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Axillary temperature	With commercial digital thermometer	Single measurement within 2 minutes of temporal artery and rectal temperature measurements	No
Primary	Rectal temperature	With thermistor probe and telethermometer	Single measurement within 2 minutes of temporal artery and axillary temperature measurements	No