N/A
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
Bottom Line
View on ClinicalTrials.gov: NCT02372071 ↗Enrolled (actual)
111
Serious AEs
0.0%
Results posted
Sep 2015
Primary outcome: Primary: BiliCare TcB Result Compared to TSB Result — 8.0; 7.3 mg/dL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- BiliCare (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Gerium Medical
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY BiliCare TcB Result Compared to TSB Result |
8.0; 7.3 | — |
Summary
The primary objective of this study is to define the performance evaluation of BiliCare TcB device to the "gold standard" bilirubin tests.
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.