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

Jaundice, Neonatal Clinical Trial

Official title:

Validation of Bilirubin Binding Capacity (BBC) Using AVIV Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02612207
• Other study ID #: IRB-24465
• Status: Completed
• Start date: August 1, 2015
• Est. completion date: August 31, 2018

Study information

• Verified date: September 2021
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 161
• Est. completion date: August 31, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 14 Days

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Device:
• Bilirubin Binding Capacity by Hematofluorometry Validation
Observation study

Locations

Country	Name	City	State
United States	AVIV Biomedical, Inc.	Lakewood	New Jersey
United States	Lucile-Packard Children's Hospital at Stanford	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Aviv Biomedical, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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