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OpenTrials
Completed

NCT Number: NCT02405429

Temporal Artery Temperature Measurement in Neonates

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.

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Key information

Conditions

Newborn Infant

Age range

Up to 6 month

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Iowa

Other

Registry information

Official study title

Comparing Temporal Artery and Axillary Temperatures With Rectal Temperature in Neonates

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Apr 1, 2015
Registry last updated
Jun 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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