Clinical Trial: Point-of-Care System for Determination of Bilirubin Capacity in Neonates

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title:

Brief Summary: The aims of this project are to validate the performance of the miniaturized and modernized hematofluorometer that measures bilirubin capacity into a product and is suitable for operation in various point of care environments when encountering confounding direct bilirubin, to complete the development of easy to use sample handling disposables, and to verify the performance of the system for samples from a specified population of neonates.

Detailed Summary:
Sponsor: Stanford University

Current Primary Outcome: Bilirubin Binding Capacity (BBC) on healthy and at-risk infants for impaired binding capacity by hematofluorometery assay [ Time Frame: <14 days of life ]

To define normative data (mean, median, range, inter-quartile ranges) among these deemed healthy infants (including those who are at- risk) for increased vulnerability to impaired binding soon after birth


Original Primary Outcome: Same as current

Current Secondary Outcome: Natural history of BBC and stratification of those at risk of disordered bilirubin binding [ Time Frame: <14 days of life ]

o delineate the prospective natural history of BBC and stratify those at most or least likely at risk of impaired bilirubin binding


Original Secondary Outcome: Same as current

Information By: Stanford University

Dates:
Date Received: November 5, 2015
Date Started: August 2015
Date Completion:
Last Updated: April 13, 2017
Last Verified: April 2017