Trials / Completed
CompletedNCT02612207
Point-of-Care System for Determination of Bilirubin Capacity in Neonates
Validation of Bilirubin Binding Capacity (BBC) Using AVIV Device
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 161 (actual)
- Sponsor
- Stanford University · Academic / Other
- Sex
- All
- Age
- 6 Hours – 14 Days
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Bilirubin Binding Capacity by Hematofluorometry Validation | Observation study |
Timeline
- Start date
- 2015-08-01
- Primary completion
- 2018-08-31
- Completion
- 2018-08-31
- First posted
- 2015-11-23
- Last updated
- 2021-09-28
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02612207. Inclusion in this directory is not an endorsement.