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 ]
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 ]
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