N/A
Completed N=111
Transcutaneous Bilirubinometry in Neonates With the BiliCare System Compared to the Invasive TSB Test
We Will Focus on Assessing the Clinical Performance of the BiliCare Device
Source: ClinicalTrials.gov NCT02372071 ↗
Enrolled (actual)
111
Serious AEs
0.0%
Results posted
Sep 2015
Primary outcomePrimary: BiliCare TcB Result Compared to TSB Result — 8.0; 7.3 mg/dL
Summary
The primary objective of this study is to define the performance evaluation of BiliCare TcB device to the "gold standard" bilirubin tests.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY BiliCare TcB Result Compared to TSB Result |
8.0; 7.3 | — |
Eligibility Criteria
Inclusion Criteria
- Signed parental informed consent
- Gestational Age >=24 weeks
Exclusion Criteria
- Less than 24 weeks of pregnancy at delivery
- Bruising at the point of measurement on both ears
- Birthmarks at the point of measurement on both ears
- Hematomas at the point of measurement on both ears
- Excessive Hairiness at the point of measurement on both ears
- Neonate is during Phototherapy or has been exposed to phototherapy treatment during the last six hours
Data sourced from ClinicalTrials.gov (NCT02372071). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.