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OpenTrials
Completed

NCT Number: NCT02445755

Transcutaneous Bilirubinometry in Neonates With the Bilicare System

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.

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Key information

Conditions

Transcutaneous Bilirubinometry

Age range

35 week and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

    Time frame: 12 to 48 hours

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 15, 2015
Registry last updated
Jun 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.