Transcutaneous Bilirubinometry in Neonates With Bilicare System
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ClinicalTrials.gov Identifier: NCT02372058 |
Recruitment Status :
Completed
First Posted : February 26, 2015
Results First Posted : September 11, 2015
Last Update Posted : September 11, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
We Will Focus on Assessing the Clinical Performance of the BiliCare Device | Device: BiliCare | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 103 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Screening |
Official Title: | Transcutaneous Bilirubinometry in Neonates With Bilicare System |
Study Start Date : | September 2014 |
Actual Primary Completion Date : | March 2015 |
Actual Study Completion Date : | March 2015 |
Arm | Intervention/treatment |
---|---|
BiliCare
Three non invasive measurements of TcB: Two measurements with the BiliCare device and one measurement with a competitive FDA approved device |
Device: BiliCare
Three non invasive measurements of TcB: Two measurements with the BiliCare device and one measurement with a competitive FDA approved device |
- BiliCare TcB Result Compared to TSB Result [ Time Frame: 30 minutes within taking the blood draw for TSB (either before or after the blood draw) ]

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Parental informed consent
- Male and female newborns with a GA ≥ 35 wks
- Enrollment at age > 6 hrs until neonatal discharge.
- Pre-phototherapy
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02372058
United States, Pennsylvania | |
Einstein Medical Center | |
Philadelphia, Pennsylvania, United States, 19141 |
Principal Investigator: | David Schutzman, MD | Einstein Medical Center |
Responsible Party: | Gerium Medical |
ClinicalTrials.gov Identifier: | NCT02372058 |
Other Study ID Numbers: |
10002 |
First Posted: | February 26, 2015 Key Record Dates |
Results First Posted: | September 11, 2015 |
Last Update Posted: | September 11, 2015 |
Last Verified: | August 2015 |