Newborn InfantNCT02405429
Temporal Artery Temperature Measurement in Neonates
An observational study of Newborn Infant, run by University of Iowa.
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. Read more about this study
- Who is it for?
- Ages Up to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Newborn Infant
- How many people
- 49 participants
- Where
- No sites listed yet
- Study dates
- May 2014to Aug 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Hospital nursery patients
Who may be able to join
- Patients in hospital well-baby nursery or neonatal intensive care unit
Who cannot join
- Birth weight <500 grams
- Anal atresia
- Central nervous system malformation
- Hypoxic-ischemic encephalopathy
- Clinical concerns for necrotizing enterocolitis or other bowel injury or discontinuity
About this study
Official title: Comparing Temporal Artery and Axillary Temperatures With Rectal Temperature 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.
- Conditions
- Newborn Infant
What is being measured
The primary outcome is the main question the study is designed to answer.
Temporal Artery Temperature
With commercial infrared temporal artery thermometer
Measured: 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
Measured: Single measurement within 2 minutes of temporal artery and rectal temperature measurements
Rectal Temperature
With thermistor probe and telethermometer
Measured: 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
Measured: Within 2 minutes of each other
Difference Between Rectal and Axillary Temperatures
Rectal temperature minus axillary temperature
Measured: Within 2 minutes of each other
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2015 (estimated)
- Study startMay 2014
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Newborn InfantStudies of the same condition, open and under way.
- More trials run by University of IowaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edward F. Bell, University of Iowa
- Investigators
- Edward F Bell, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02405429
- Sponsor's protocol ID
- 201404832
- Status last verified
- May 2017
- First submitted
- 25 Mar 2015
- Last updated
- 14 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Syrkin-Nikolau ME, Johnson KJ, Colaizy TT, Schrock R, Bell EF. Temporal Artery Temperature Measurement in the Neonate. Am J Perinatol. 2017 Aug;34(10):1026-1031. doi: 10.1055/s-0037-1601440. Epub 2017 Apr 10.
PubMed 28395367
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Temporal Artery and Axillary Temperatures With Rectal Temperature in Neonates
- ClinicalTrials.gov ID
- NCT02405429
- Acronym / sponsor ID
- 201404832
- Conditions
- Newborn Infant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 1 Apr 2015 (estimated)
- Results
- Posted 20 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Hospital nursery patients
Key inclusion criteria (1 listed)
- Patients in hospital well-baby nursery or neonatal intensive care unit
Key exclusion criteria (5 listed)
- Birth weight <500 grams
- Anal atresia
- Central nervous system malformation
- Hypoxic-ischemic encephalopathy
- Clinical concerns for necrotizing enterocolitis or other bowel injury or discontinuity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Axillary Temperature
Time frame: Single measurement within 2 minutes of temporal artery and rectal temperature measurements
With commercial digital thermometer
Rectal Temperature
Time frame: Single measurement within 2 minutes of temporal artery and axillary temperature measurements
With thermistor probe and telethermometer
Difference Between Temporal Artery and Rectal Temperatures
Time frame: Within 2 minutes of each other
Rectal temperature minus temporal artery temperature
Difference Between Rectal and Axillary Temperatures
Time frame: Within 2 minutes of each other
Rectal temperature minus axillary temperature
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 28395367Syrkin-Nikolau ME, Johnson KJ, Colaizy TT, Schrock R, Bell EF. Temporal Artery Temperature Measurement in the Neonate. Am J Perinatol. 2017 Aug;34(10):1026-1031. doi: 10.1055/s-0037-1601440. Epub 2017 Apr 10.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward F Bell, MD principal investigator
University of Iowa
Questions about this trial
What is this clinical trial studying?
An observational study of Newborn Infant, run by University of Iowa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02405429, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2017.