N/A
N=103
Transcutaneous Bilirubinometry in Neonates With Bilicare System
We Will Focus on Assessing the Clinical Performance of the BiliCare Device
Bottom Line
View on ClinicalTrials.gov: NCT02372058 ↗Enrolled (actual)
103
Serious AEs
0.0%
Results posted
Sep 2015
Primary outcome: Primary: BiliCare TcB Result Compared to TSB Result — 8.46; 7.93; 7.83 mg/dL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- BiliCare (Device)
- Age
- Pediatric, Adult, Older Adult · 0+ yrs
- Sex
- All
- Sponsor
- Gerium Medical
- Primary completion
- Mar 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY BiliCare TcB Result Compared to TSB Result |
8.46; 7.93; 7.83 | — |
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
- 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
Data sourced from ClinicalTrials.gov (NCT02372058). 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.