Newborn InfantsNCT00762489
Comparison of Three Methods of Taking Temperatures in the Well Baby Nursery
A study testing Temporal artery thermometer temperature in people with Newborn Infants, run by Christiana Care Health Services at 1 site in United States.
Trial summary
Body temperature measurement is one of the standard vital sign measurements in newborn babies in order assess their health status. Temperatures are taken on a regular basis throughout the newborn's stay on the well-baby floor. Read more about this study
- Who is it for?
- Ages Up to 24 hoursHealthy volunteers can take part
- Conditions the study is for
- Newborn Infants
- What is being tested?
- Temporal artery thermometer temperature
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Aug 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 24 hours
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- term newborns >/= 37 weeks gestational age
- late preterm infants >/= 35 weeks gestational age
- admitted to the well baby nursery following delivery
- < 24 hours of age
Who cannot join
- Infants < 35 weeks gestational age
- Infants currently under a radiant warmer or who have been under a radiant warmer < 1 hour prior to temperature measurement.
Trial locations and contacts
1 site in 1 country.
United States1 site
Christiana Care Health Systems
Newark, Delaware, 19713
About this study
Official title: Comparison of Temporal Artery, Axillary, and Rectal Temperatures in Newborn Patients in the Well Baby Nursery.
Body temperature measurement is one of the standard vital sign measurements in newborn babies in order assess their health status. Temperatures are taken on a regular basis throughout the newborn's stay on the well-baby floor. A temperature that is elevated above the normal range for age or depressed below the normal range for age may be a sign of illness in a newborn. There are many methods that may be used to record this temperature. Traditionally, axillary (under the arm) and rectal (in the rectum) sites have been used. Recently, a new method of temperature measurement has become available. Temporal artery thermometers are a non-invasive method to measure the baby's temperature by means of a light that is shone on the forehead that can read your baby's temperature quickly. It is not clear whether this method is accurate in the newborn period.
The purpose of this study is to evaluate the accuracy of temporal artery temperature measurement. This will be achieved by observing the axillary measurement, rectal temperature measurement, and temporal artery temperature measurement taken at approximately the same time in each infant. These measurements will be compared to each other to determine if temporal artery thermometry is as reliable a measurement as rectal and / or axillary temperature measurements.
Read more
We plan to compare
Hypothesis: Temporal artery thermometry of the immediate newborn infant is an accurate measurement of temperature in this age group.
- Conditions
- Newborn Infants
- Being tested
- Temporal artery thermometer temperature
- Keywords
- Temporal artery thermometry, Rectal temperature, Axillary temperature, Newborns, Temperature measurement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temporal artery thermometer temperatureOther
Also called Exergen TAT-5000 TemporalScanner Exergen Corp; Watertown, MA)
Newborn infants had a temporal artery temperature taken within a few minutes of the axillary and rectal temperatures. The axillary and rectal temperatures are taken via methods which are standard of care.
| Study group | Role | What they receive |
|---|---|---|
| TAT vs. RT | Other | This arm is comparing the Temporal Artery Thermometer (TAT) temperature to the Rectal Temperature (RT). Receives: Other: Temporal artery thermometer temperature |
| TAT vs. AT | Other | This arm is comparing the Temporal Artery Thermometer (TAT) temperature to the Axillary Temperature (AT). Receives: Other: Temporal artery thermometer temperature |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of temporal artery temperature compared to rectal and axillary temperature measurements.
Measured: All temperatures will be taken within 5 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 posted30 Sep 2008 (estimated)
- Study startOct 2008
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newborn InfantsStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Single group
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christiana Care Health Services
- Sponsor type
- University, hospital or other
- Investigators
- Michael F. Bruno, MD, Principal investigator, Christiana Care Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00762489
- Sponsor's protocol ID
- 28148
- Status last verified
- Apr 2011
- First submitted
- 29 Sep 2008
- Last updated
- 29 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Temporal Artery, Axillary, and Rectal Temperatures in Newborn Patients in the Well Baby Nursery.
- ClinicalTrials.gov ID
- NCT00762489
- Acronym / sponsor ID
- 28148
- Conditions
- Newborn Infants
- Keywords
- Temporal artery thermometry, Rectal temperature, Axillary temperature, Newborns, Temperature measurement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Christiana Care Health ServicesUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 30 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Body temperature measurement is one of the standard vital sign measurements in newborn babies in order assess their health status. Temperatures are taken on a regular basis throughout the newborn's stay on the well-baby floor. A temperature that is elevated above the normal range for age or depressed below the normal range for age may be a sign of illness in a newborn. There are many methods that may be used to record this temperature. Traditionally, axillary (under the arm) and rectal (in the rectum) sites have been used. Recently, a new method of temperature measurement has become available. Temporal artery thermometers are a non-invasive method to measure the baby's temperature by means of a light that is shone on the forehead that can read your baby's temperature quickly. It is not clear whether this method is accurate in the newborn period.
The purpose of this study is to evaluate the accuracy of temporal artery temperature measurement. This will be achieved by observing the axillary measurement, rectal temperature measurement, and temporal artery temperature measurement taken at approximately the same time in each infant. These measurements will be compared to each other to determine if temporal artery thermometry is as reliable a measurement as rectal and / or axillary temperature measurements.
We plan to compare
Hypothesis: Temporal artery thermometry of the immediate newborn infant is an accurate measurement of temperature in this age group.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAT vs. RT | Other | Other: Temporal artery thermometer temperatureThis arm is comparing the Temporal Artery Thermometer (TAT) temperature to the Rectal Temperature (RT). |
| TAT vs. AT | Other | Other: Temporal artery thermometer temperatureThis arm is comparing the Temporal Artery Thermometer (TAT) temperature to the Axillary Temperature (AT). |
Who may qualify
- Ages
- Up to 24 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- term newborns >/= 37 weeks gestational age
- late preterm infants >/= 35 weeks gestational age
- admitted to the well baby nursery following delivery
- < 24 hours of age
Key exclusion criteria (2 listed)
- Infants < 35 weeks gestational age
- Infants currently under a radiant warmer or who have been under a radiant warmer < 1 hour prior to temperature measurement.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Temporal artery thermometer temperatureAlso: Exergen TAT-5000 TemporalScanner Exergen Corp; Watertown, MA)Newborn infants had a temporal artery temperature taken within a few minutes of the axillary and rectal temperatures. The axillary and rectal temperatures are taken via methods which are standard of care. | Other | TAT vs. AT, TAT vs. RT |
Primary outcome
Accuracy of temporal artery temperature compared to rectal and axillary temperature measurements.
Time frame: All temperatures will be taken within 5 minutes of each other
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2011.
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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.
Michael F. Bruno, MD principal investigator
Christiana Care Health Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Temporal artery thermometer temperature in people with Newborn Infants, run by Christiana Care Health Services at 1 site in United States.
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 4 inclusion and 2 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 29 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Accuracy of temporal artery temperature compared to rectal and axillary temperature measurements. (time frame: All temperatures will be taken within 5 minutes of each other). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Apr 2011.