Transcutaneous Bilirubinometry in Neonates With the Bilicare System

NCT ID: NCT02445755

Last Updated: 2015-06-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 113 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2015-05-31

Brief 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.

Conditions

Transcutaneous Bilirubinometry

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 35 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Vinod K. Bhutani

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

30820

Identifier Type: -

Identifier Source: org_study_id

NCT02372045

Identifier Type: -

Identifier Source: nct_alias