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

Status:	Recruiting
Conditions:	Gastrointestinal
Therapuetic Areas:	Gastroenterology
Healthy:	No
Age Range:	Any
Updated:	4/21/2016
Start Date:	August 2015

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.

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:

We found this trial at

sites

Albert Enstein Medical Center

Philadelphia, Pennsylvania 19141

Principal Investigator: David L Schutzman, MD

Phone: 215-456-6698

from

Philadelphia, PA