Stanford, California 94305

  • Induced Neurological Dysfunction (BIND)

Purpose:

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.


Criteria:

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:


NCT ID:

NCT02612207


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Stanford, California 94305
United States

Vinod K Bhutani, MD
Phone: 650-723-5711
Email: bhutani@stanford.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 16, 2021

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