Transcutaneous Bilirubinometry in Neonates With the Bilicare System

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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

  • 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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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