Bilirubin-Induced Neurological Dysfunction (BIND), Hyperbilirubinemia, Jaundice, Neonatal
Conditions
Keywords
Bilirubin Binding Capacity Preterm Neonates and Jaundice
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).
Interventions
DEVICEBilirubin Binding Capacity by Hematofluorometry Validation
Observation study
Sponsors
Aviv Biomedical, Inc.
Stanford University
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Hours to 14 Days
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed