ThermometryNCT01012128
Comparison of Three Methods of Taking Temperatures in the Newborn Intensive Care Unit
An observational study of Thermometry, run by Christiana Care Health Services at 1 site in United States.
Trial summary
Preterm infants will have their body temperature measured by three different devices in order to evaluate whether the newest device, a temporal artery scanning thermometer, is accurate for patients in the preterm period. Read more about this study
- Who is it for?
- Ages Up to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Thermometry
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Dec 2011
- Phase
- Observational
- 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 6 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Preterm infants corrected to 30-35 weeks gestation
Who may be able to join
- preterm infants corrected to 30-35 weeks gestation
- current incubator set on air control between 28-30 degrees centigrade
Who cannot join
- infants <30 and >35 weeks gestation
- infants requiring > 30 degrees centigrade in incubator on air control
- infants currently not in an incubator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Temporal Artery, Axillary, and Rectal Temperatures in Preterm Infants in the NICU
Preterm infants will have their body temperature measured by three different devices in order to evaluate whether the newest device, a temporal artery scanning thermometer, is accurate for patients in the preterm period.
- Conditions
- Thermometry
- Keywords
- Temporal Artery Thermometer, Temperature, Preterm Infants
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of temporal artery thermometer measurements
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2009 (estimated)
- Study startJan 2010
- Primary completionJan 2011 (estimated)
- Study completionDec 2011 (estimated)
Why it stopped: Closed: logistical problems that could not be resolved.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThermometryStudies 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 0 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 Hospital / Christiana Care Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01012128
- Sponsor's protocol ID
- 600687
- Status last verified
- Apr 2015
- First submitted
- 9 Nov 2009
- Last updated
- 6 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Temporal Artery, Axillary, and Rectal Temperatures in Preterm Infants in the NICU
- ClinicalTrials.gov ID
- NCT01012128
- Acronym / sponsor ID
- 600687
- Conditions
- Thermometry
- Keywords
- Temporal Artery Thermometer, Temperature, Preterm Infants
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Closed: logistical problems that could not be resolved.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Christiana Care Health ServicesUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jan 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 11 Nov 2009 (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.
Preterm infants will have their body temperature measured by three different devices in order to evaluate whether the newest device, a temporal artery scanning thermometer, is accurate for patients in the preterm period.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Preterm infants corrected to 30-35 weeks gestation
Key inclusion criteria (2 listed)
- preterm infants corrected to 30-35 weeks gestation
- current incubator set on air control between 28-30 degrees centigrade
Key exclusion criteria (3 listed)
- infants <30 and >35 weeks gestation
- infants requiring > 30 degrees centigrade in incubator on air control
- infants currently not in an incubator
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
Accuracy of temporal artery thermometer measurements
Time frame: 5 minutes
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2015.
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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 Hospital / Christiana Care Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thermometry, 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 2 inclusion and 3 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: withdrawn, as of the sponsor's last update on 6 Apr 2015. 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 was withdrawn before enrolling participants, so there are no results.
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 thermometer measurements (time frame: 5 minutes). 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 6 Apr 2015.