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

Validation of Bilirubin Binding Capacity (BBC) Using AVIV Device

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.

Study Overview

• Status: Completed
• Conditions: Hyperbilirubinemia; Jaundice, Neonatal; Bilirubin-Induced Neurological Dysfunction (BIND)
• Intervention / Treatment: Device: Bilirubin Binding Capacity by Hematofluorometry Validation

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).

• Study Type: Observational
• Enrollment (Actual): 161

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Lucile-Packard Children's Hospital at Stanford
  • New Jersey
    • Lakewood, New Jersey, United States, 08701
      • AVIV Biomedical, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 hours to 2 weeks (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of preterm (≥ 24 wks GA, BW≥500g) as well as sick or unstable late-term newborns (infants ≥ 35 wks GA, BW≥2500g).

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: Aviv Biomedical, Inc.
• Investigators: Principal Investigator: Vinod K Bhutani, MD, PI

Publications and helpful links

General Publications

• Lamola AA, Bhutani VK, Du L, Castillo Cuadrado M, Chen L, Shen Z, Wong RJ, Stevenson DK. Neonatal bilirubin binding capacity discerns risk of neurological dysfunction. Pediatr Res. 2015 Feb;77(2):334-9. doi: 10.1038/pr.2014.191. Epub 2014 Nov 24.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2015
• Primary Completion (ACTUAL): August 31, 2018
• Study Completion (ACTUAL): August 31, 2018

Study Registration Dates

• First Submitted: November 5, 2015
• First Submitted That Met QC Criteria: November 19, 2015
• First Posted (ESTIMATE): November 23, 2015

Study Record Updates

• Last Update Posted (ACTUAL): September 28, 2021
• Last Update Submitted That Met QC Criteria: September 24, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Bilirubin Binding Capacity Preterm Neonates and Jaundice
• Additional Relevant MeSH Terms: Pathologic Processes; Infant, Newborn, Diseases; Skin Manifestations; Hyperbilirubinemia, Neonatal; Jaundice; Hyperbilirubinemia; Jaundice, Neonatal; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Antioxidants; Bilirubin
• Other Study ID Numbers: IRB-24465