Transcutaneous Bilirubinometry in Neonates With the Bilicare System
Completed
- Conditions
- Transcutaneous Bilirubinometry
- Registration Number
- NCT02445755
- Lead Sponsor
- Stanford University
- Brief 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. If the investigators can validate the BiliCare™ with bilirubin from your baby's blood they could verify a non-invasive alternative for measuring bilirubin.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 113
Inclusion Criteria
- Parental informed consent
- Male and female newborns with a GA ≥ 35 wks
- Enrollment at age > 6 hrs until neonatal discharge
- Pre-phototherapy
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Exclusion Criteria
- 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
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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. 12 to 48 hours
- Secondary Outcome Measures
Name Time Method