Transcutaneous BilirubinometryNCT02445755
Transcutaneous Bilirubinometry in Neonates With the Bilicare System
An observational study of Transcutaneous Bilirubinometry, run by Stanford University.
Trial summary
The purpose of this study is to test the performance of a new transcutaneous ("measured through skin") bilirubin device (BiliCare™) to measure bilirubin levels. The investigators plan to evaluate the clinical performance of this device as a point of care test. Read more about this study
- Who is it for?
- Ages 35 weeks and older
- Conditions the study is for
- Transcutaneous Bilirubinometry
- How many people
- 113 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to May 2015
- 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 35 weeks and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Up to 100 total participants will be enrolled by the study. Since the goal of the study is to ASSAY SAMPLE FROM BABIES WITH DIVERSE BILIRUBIN LEVELS, the study participants will be moderate premature and mature infants. In particular, the target population will be moderate premature infants at >35 weeks postmenstrual age (PMA) and of term PMA.
Who may be able to join
- Parental informed consent
- Male and female newborns with a GA ≥ 35 wks
- Enrollment at age > 6 hrs until neonatal discharge
- Pre-phototherapy
Who cannot join
- Infants requiring respiratory assistance (such as mechanical ventilation)
- Severe or life-threatening congenital anomalies
- Hematomas at the point of measurement on both ears
- Neonates undergone blood transfusion
About this study
The purpose of this study is to test the performance of a new transcutaneous ("measured through skin") bilirubin device (BiliCare™) to measure bilirubin levels. The investigators plan to evaluate the clinical performance of this device as a point of care test. If the investigators can validate the BiliCare™ with bilirubin from your baby's blood they could verify a non-invasive alternative for measuring bilirubin.
- Conditions
- Transcutaneous Bilirubinometry
- Keywords
- Neonates, Bilicare System
What is being measured
The primary outcome is the main question the study is designed to answer.
In This Study, the Investigators Plan to Test the Performance of a Novel Transcutaneous Device (BiliCareTM) to Screen for Bilirubin Levels at Postnatal Age of 12 to 48 Hours.
Measured: 12 to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2015 (estimated)
- Study startJun 2014
- Primary completionMay 2015
- Study completionMay 2015
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.
- Other trials for Transcutaneous BilirubinometryStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Prospective
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vinod K. Bhutani, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02445755
- Sponsor's protocol ID
- 30820
- Status last verified
- May 2015
- First submitted
- 13 May 2015
- Last updated
- 4 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Bilirubinometry in Neonates With the Bilicare System
- ClinicalTrials.gov ID
- NCT02445755
- Acronym / sponsor ID
- 30820
- Conditions
- Transcutaneous Bilirubinometry
- Keywords
- Neonates, Bilicare System
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 15 May 2015 (estimated)
- Results
- Posted 4 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test the performance of a new transcutaneous ("measured through skin") bilirubin device (BiliCare™) to measure bilirubin levels. The investigators plan to evaluate the clinical performance of this device as a point of care test. If the investigators can validate the BiliCare™ with bilirubin from your baby's blood they could verify a non-invasive alternative for measuring bilirubin.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 35 weeks and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Up to 100 total participants will be enrolled by the study. Since the goal of the study is to ASSAY SAMPLE FROM BABIES WITH DIVERSE BILIRUBIN LEVELS, the study participants will be moderate premature and mature infants. In particular, the target population will be moderate premature infants at >35 weeks postmenstrual age (PMA) and of term PMA.
Key inclusion criteria (4 listed)
- Parental informed consent
- Male and female newborns with a GA ≥ 35 wks
- Enrollment at age > 6 hrs until neonatal discharge
- Pre-phototherapy
Key exclusion criteria (4 listed)
- Infants requiring respiratory assistance (such as mechanical ventilation)
- Severe or life-threatening congenital anomalies
- Hematomas at the point of measurement on both ears
- Neonates undergone blood transfusion
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
In This Study, the Investigators Plan to Test the Performance of a Novel Transcutaneous Device (BiliCareTM) to Screen for Bilirubin Levels at Postnatal Age of 12 to 48 Hours.
Time frame: 12 to 48 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Transcutaneous Bilirubinometry
Not yet recruiting
Transcutaneous Bilirubinometry and Phototherapy
Neonatal Hyperbilirubinemia
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Transcutaneous Bilirubinometry, run by Stanford University.
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 4 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 4 Jun 2015. 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 4 Jun 2015). 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?
In This Study, the Investigators Plan to Test the Performance of a Novel Transcutaneous Device (BiliCareTM) to Screen for Bilirubin Levels at Postnatal Age of 12 to 48 Hours. (time frame: 12 to 48 hours). 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 4 Jun 2015.