N/A
Completed N=113
Transcutaneous Bilirubinometry in Neonates With the Bilicare System
Transcutaneous Bilirubinometry
Source: ClinicalTrials.gov NCT02445755 ↗
Enrolled (actual)
113
Serious AEs
0.0%
Results posted
Jun 2015
Primary outcomePrimary: 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. — 7.5; 7.6; 6.1; 6.4 mg/dL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
7.5; 7.6; 6.1; 6.4 | — |
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 (NCT02445755). 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.