Trial Search Results

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

The aims of this 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 when encountering confounding direct bilirubin, to complete the development of easy to use sample handling disposables, and to verify the performance of the system for samples from a specified population of neonates.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Stanford University

Collaborator: Aviv Biomedical, Inc.

Stanford Investigator(s):

Intervention(s):

  • Device: Bilirubin Binding Capacity by hematofluorometry

Eligibility


Inclusion Criteria:

   - 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 ≥ 28 wks with a birthweight ≥ 1000 g including
      infants with GA ≥ 35 wks with a birthweight ≥ 2500 g who are clinically deemed at
      risk.

      - Enrollment at age less than 14 days and more than 6h

Exclusion Criteria:

   - None.

Ages Eligible for Study

N/A - 14 Days

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Vinod K Bhutani, MD
650-723-5711
Recruiting