An observational study in Newborn Infant, sponsored by University of Iowa. Completed. Open to participants aged Up to 6 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-06-14.
Sponsored by University of Iowa · Observational
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.
University of Iowa is the lead sponsor of 276 studies on the registry; 35 are open to participants now.
Of its 44 completed or terminated interventional studies of FDA-regulated products, 39 (89%) have results posted.
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Hospital nursery patients
Exclusion Criteria:
Temporal Artery Temperature
With commercial infrared temporal artery thermometer
Time frame: 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
Time frame: Single measurement within 2 minutes of temporal artery and rectal temperature measurements
Rectal Temperature
With thermistor probe and telethermometer
Time frame: 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
Time frame: Within 2 minutes of each other
Difference Between Rectal and Axillary Temperatures
Rectal temperature minus axillary temperature
Time frame: Within 2 minutes of each other
| Milestone | Hospitalized Neonates |
|---|---|
| Started | 49 |
| Completed | 49 |
| Not completed | 0 |
With commercial infrared temporal artery thermometer
| degrees Celsius | Hospitalized Neonates |
|---|---|
| Temporal Artery Temperature | 37.16 ± 0.36 |
With commercial digital thermometer
| degrees Celsius | Hospitalized Neonates |
|---|---|
| Axillary Temperature | 36.61 ± 0.30 |
With thermistor probe and telethermometer
| degrees Celsius | Hospitalized Neonates |
|---|---|
| Rectal Temperature | 36.82 ± 0.30 |
Rectal temperature minus temporal artery temperature
| degrees Celsius | Hospitalized Neonates |
|---|---|
| Difference Between Temporal Artery and Rectal Temperatures | -0.34 ± 0.37 |
Rectal temperature minus axillary temperature
| degrees Celsius | Hospitalized Neonates |
|---|---|
| Difference Between Rectal and Axillary Temperatures | 0.21 ± 0.26 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Hospitalized Neonates | 0/49 (0%) | 0/49 (0%) | 0/49 (0%) |
| Age, Categorical(Participants) | Hospitalized Neonates |
|---|---|
| <=18 years | 49 |
| Between 18 and 65 years | 0 |
| >=65 years | 0 |
| Age, Continuous(days) | Hospitalized Neonates |
|---|---|
| Median | 11 (1 to 78) |
| Sex: Female, Male(Participants) | Hospitalized Neonates |
|---|---|
| Female | 23 |
| Male | 26 |
| Race and Ethnicity Not Collected(Participants) | Hospitalized Neonates |
|---|
| Region of Enrollment(participants) | Hospitalized Neonates |
|---|---|
| United States | 49 |
| Gestational Age(weeks) | Hospitalized Neonates |
|---|---|
| Median | 34 (25 to 40) |
| Body Weight at Time of Study(grams) | Hospitalized Neonates |
|---|---|
| Median | 2235 (1160 to 4205) |
No study locations are listed for this record.
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University of Iowa