Transcutaneous Bilirubinometry in Neonates With the Bilicare System

May 20, 2015 updated by: Vinod K. Bhutani, Stanford University
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

113

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 months and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Up to 100 total participants will be enrolled by the study. Since the goal of the study is to ASSAY SAMPLE FROM BABIES WITH DIVERSE BILIRUBIN LEVELS, the study participants will be moderate premature and mature infants. In particular, the target population will be moderate premature infants at >35 weeks postmenstrual age (PMA) and of term PMA.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
12 to 48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

May 13, 2015

First Submitted That Met QC Criteria

May 14, 2015

First Posted (Estimate)

May 15, 2015

Study Record Updates

Last Update Posted (Estimate)

June 4, 2015

Last Update Submitted That Met QC Criteria

May 20, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 30820

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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