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

Stanford University

Status: Completed

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

Treatments: Device: Bilirubin Binding Capacity by Hematofluorometry Validation

Study type: Observational

Funder types: Other

Identifiers

NCT02612207

IRB-24465

Details and patient eligibility

About

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.

Full 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).

Enrollment: 161 patients

Sex: All

Ages: 6 hours to 14 days old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.