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

Study Overview
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Brief Summary
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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
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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).

Official Title
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Validation of Bilirubin Binding Capacity (BBC) Using AVIV Device

Conditions
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Jaundice, Neonatal, Hyperbilirubinemia, Bilirubin-Induced Neurological Dysfunction (BIND)

Intervention / Treatment
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* Device: Bilirubin Binding Capacity by Hematofluorometry Validation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria are in vitro testing of blood samples obtained from eligible babies: Subjects must meet all of the following inclusion criteria to be considered eligible for study enrollment soon after birth or re-admission (for phototherapy): Parental informed consent Male and female newborns with a GA ≥ 24 wks with a birthweight ≥ 500 g as well as sick or unstable late preterm newborns infants with GA ≥ 35 wks with a birthweight ≥ 2500 g. Enrollment at age less than 14 days and more than 6h Exclusion Criteria: None.

Ages Eligible for Study
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Minimum Age: 6 Hours
Maximum Age: 14 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Bilirubin Binding Capacity by Hematofluorometry Validation|Observation study|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bilirubin Binding Capacity (BBC) on healthy and at-risk infants for impaired binding capacity by hematofluorometery assay | 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 | <14 days of life | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Natural history of BBC and stratification of those at risk of disordered bilirubin binding | To delineate the prospective natural history of BBC and stratify those at most or least likely at risk of impaired bilirubin binding | <14 days of life | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bilirubin Binding Capacity Preterm Neonates and Jaundice