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

NCT ID: NCT02612207

Last Updated: 2021-09-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 161 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-08-01
• Study Completion Date: 2018-08-31

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).

Conditions

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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

Bilirubin Binding Capacity by Hematofluorometry Validation

Observation study

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 6 Hours
• Maximum Eligible Age: 14 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Aviv Biomedical, Inc.

UNKNOWN

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vinod K Bhutani, MD

Role: PRINCIPAL_INVESTIGATOR

PI

Locations

Lucile-Packard Children's Hospital at Stanford

Stanford, California, United States

AVIV Biomedical, Inc.

Lakewood, New Jersey, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 25420178 (View on PubMed)

Other Identifiers

IRB-24465

Identifier Type: -

Identifier Source: org_study_id