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