Temporal Artery Temperature Measurement in Neonates

Comparing Temporal Artery and Axillary Temperatures With Rectal Temperature in Neonates

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02405429

Enrollment

Registered

2015-04-01

Start date

2014-05-31

Completion date

2014-08-31

Last updated

2017-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Newborn Infant

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

No minimum to 6 Months

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Difference Between Rectal and Axillary Temperatures	Within 2 minutes of each other	Rectal temperature minus axillary temperature
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

Participant flow

Participants by arm

Arm	Count
Hospitalized Neonates Patients in the neonatal intensive care unit or the newborn nursery	49
Total	49

Baseline characteristics

Characteristic	Hospitalized Neonates	—
Age, Categorical <=18 years	49 Participants	—
Age, Categorical >=65 years	0 Participants	—
Age, Categorical Between 18 and 65 years	0 Participants	—
Age, Continuous	11 days	—
Body Weight at Time of Study	2235 grams	—
Gestational Age	34 weeks	—
Race and Ethnicity Not Collected	—	— Participants
Region of Enrollment United States	49 participants	—
Sex: Female, Male Female	23 Participants	—
Sex: Female, Male Male	26 Participants	—

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 49
other Total, other adverse events	0 / 49
serious Total, serious adverse events	0 / 49

Outcome results

Primary

Axillary Temperature

With commercial digital thermometer

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