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Point-of-Care System for Determination of Bilirubin Capacity in Neonates
Not Recruiting
Trial ID: NCT02612207
Purpose
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.
Official Title
Validation of Bilirubin Binding Capacity (BBC) Using AVIV Device
Stanford Investigator(s)
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.
Intervention(s):
device: Bilirubin Binding Capacity by Hematofluorometry Validation
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Vinod K Bhutani, MD
650-723-5711