Transcutaneous Bilirubinometry in Neonates With Bilicare System

Completed · Not applicable

Conditions studied: We Will Focus on Assessing the Clinical Performance of the BiliCare Device

In brief

The primary objective of this study is to define the performance evaluation of BiliCare TcB device to the "gold standard" bilirubin tests.

Key facts

Study ID

NCT02372058

Run by

Gerium Medical

People needed

103

Starts

2014-09-01

Expected to finish

2015-03-01

Last updated by the study team

2015-09-11

Who can join

Age: 0 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Parental informed consent
• Male and female newborns with a GA ≥ 35 wks
• Enrollment at age > 6 hrs until neonatal discharge.
• Pre-phototherapy

You may not qualify if…

• 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

Where it is running

• Einstein Medical Center — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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