Clinical trial NCT02612207: Point-of-Care System for Determination of Bilirubin Capacity in Neonates
Official title: Validation of Bilirubin Binding Capacity (BBC) Using AVIV Device
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Jaundice, Neonatal
Hyperbilirubinemia
Bilirubin-Induced Neurological Dysfunction (BIND)
Keywords: Bilirubin Binding Capacity Preterm Neonates and Jaundice
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Aviv Biomedical, Inc.
First posted: 2015-11-23
Enrollment: 161
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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).

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).

Eligibility 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.

Primary outcomes:
measure: Bilirubin Binding Capacity (BBC) on healthy and at-risk infants for impaired binding capacity by hematofluorometery assay
timeFrame: <14 days of life
Secondary outcomes:
measure: Natural history of BBC and stratification of those at risk of disordered bilirubin binding
timeFrame: <14 days of life
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Lucile-Packard Children's Hospital at Stanford
state: California
city: Lakewood
country: United States
facility: AVIV Biomedical, Inc.
state: New Jersey
Study officials:
affiliation: PI
name: Vinod K Bhutani, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.