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Point-of-Care System for Determination of Bilirubin Capacity in Neonates

Completed
Conditions
Bilirubin-Induced Neurological Dysfunction (BIND)
Hyperbilirubinemia
Jaundice, Neonatal
Registration Number
NCT02612207
Lead Sponsor
Stanford University
Brief Summary

The aims of this observational bench 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 w in the management of preterm neonates.

Detailed Description

The status of bilirubin binding to albumin (Alb) is central to personalized management of unconjugated newborn hyperbilirubinemia, especially those at risk of bilirubin-induced neurologic dysfunction (BIND) (1). Our objectives were to validate the Aviv Bili-4 Hematofluorometer in the context of its usefulness and ease of use based on ad hoc clinical studies and surveys of end-users. In addition, we continued our efforts to validate the Bili-4 device in order to facilitate Aviv, Inc. in their development of claims of the most appropriate use of bilirubin binding capacity (BBC) information in the management of neonates. Neonatal blood samples were obtained from newborns born at Stanford University's LPCH with gestational ages (GA) ranging from 22-40 wks. Total bilirubin (TB), Alb and apparent serum unbound bilirubin (UB) concentrations were measured or calculated. Ratios of bound bilirubin (BB) to reserve Alb binding capacity for bilirubin (RABC) were also determined. Bilirubin binding capacity (BBC) by hematofluorometry (Hmf) was compared to the calculated BBC (or 8.8 × Alb) using Alb levels as measured by the clinical laboratory. We report the progress of this inquiry at the Stanford University (1).

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
161
Inclusion Criteria

Not provided

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Exclusion Criteria
  • None.
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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Bilirubin Binding Capacity (BBC) on healthy and at-risk infants for impaired binding capacity by hematofluorometery assay<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

Secondary Outcome Measures
NameTimeMethod
Natural history of BBC and stratification of those at risk of disordered bilirubin binding<14 days of life

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

Trial Locations

Locations (2)

AVIV Biomedical, Inc.

🇺🇸

Lakewood, New Jersey, United States

Lucile-Packard Children's Hospital at Stanford

🇺🇸

Stanford, California, United States

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