Transcutaneous Bilirubinometry in Neonates With the Bilicare System

Stanford University

Status: Completed

Conditions: Transcutaneous Bilirubinometry

Study type: Observational

Funder types: Other

Identifiers

NCT02445755

30820

Details and patient eligibility

About

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.

Enrollment: 113 patients

Sex: All

Ages: 35+ weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Infants requiring respiratory assistance (such as mechanical ventilation)
2. Severe or life-threatening congenital anomalies
3. Hematomas at the point of measurement on both ears
4. Neonates undergone blood transfusion