Trial Outcomes & Findings for Temporal Artery Temperature Measurement in Neonates (NCT NCT02405429)

NCT ID: NCT02405429

Last Updated: 2017-06-14

Results Overview

With commercial infrared temporal artery thermometer

• Recruitment status: COMPLETED
• Target enrollment: 49 participants
• Primary outcome timeframe: Mean of 2 measurements within 2 minutes of each other and within 2 minutes of axillary and rectal temperature measurements
• Results posted on: 2017-06-14

Participant Flow

Participant milestones

Measure	Hospitalized Neonates Patients in the neonatal intensive care unit or the newborn nursery
Overall Study STARTED	49
Overall Study COMPLETED	49
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Hospitalized Neonates n=49 Participants Patients in the neonatal intensive care unit or the newborn nursery
Age, Categorical <=18 years	49 Participants n=49 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=49 Participants
Age, Categorical >=65 years	0 Participants n=49 Participants
Age, Continuous	11 days n=49 Participants
Sex: Female, Male Female	23 Participants n=49 Participants
Sex: Female, Male Male	26 Participants n=49 Participants
Region of Enrollment United States	49 participants n=49 Participants
Gestational Age	34 weeks n=49 Participants
Body Weight at Time of Study	2235 grams n=49 Participants

PRIMARY outcome

Timeframe: Mean of 2 measurements within 2 minutes of each other and within 2 minutes of axillary and rectal temperature measurements

Population: Hospitalized neonates

With commercial infrared temporal artery thermometer

Outcome measures

Measure	Hospitalized Neonates n=49 Participants Patients in the neonatal intensive care unit or the newborn nursery
Temporal Artery Temperature	37.16 degrees Celsius Standard Deviation 0.36

PRIMARY outcome

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

Population: Hospitalized neonates

With commercial digital thermometer

Outcome measures

Measure	Hospitalized Neonates n=49 Participants Patients in the neonatal intensive care unit or the newborn nursery
Axillary Temperature	36.61 degrees Celsius Standard Deviation 0.30

PRIMARY outcome

Timeframe: Single measurement within 2 minutes of temporal artery and axillary temperature measurements

Population: Hospitalized neonates

With thermistor probe and telethermometer

Outcome measures

Measure	Hospitalized Neonates n=49 Participants Patients in the neonatal intensive care unit or the newborn nursery
Rectal Temperature	36.82 degrees Celsius Standard Deviation 0.30

PRIMARY outcome

Timeframe: Within 2 minutes of each other

Population: Hospitalized neonates

Rectal temperature minus temporal artery temperature

Outcome measures

Measure	Hospitalized Neonates n=49 Participants Patients in the neonatal intensive care unit or the newborn nursery
Difference Between Temporal Artery and Rectal Temperatures	-0.34 degrees Celsius Standard Deviation 0.37

PRIMARY outcome

Timeframe: Within 2 minutes of each other

Population: Hospitalized neonates

Rectal temperature minus axillary temperature

Outcome measures

Measure	Hospitalized Neonates n=49 Participants Patients in the neonatal intensive care unit or the newborn nursery
Difference Between Rectal and Axillary Temperatures	0.21 degrees Celsius Standard Deviation 0.26

Adverse Events

Hospitalized Neonates

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Edward F. Bell, MD

University of Iowa

Phone: 319-356-4006

Email: edward-bell@uiowa.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place