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RECRUITING
NCT03866213

Validation of a Jaundice Diagnostic and Monitoring Device for Low-Resource Settings

Sponsor: William Marsh Rice University

View on ClinicalTrials.gov

Summary

A team of researchers at Rice University in partnership with clinicians at Queen Elizabeth Central Hospital created BiliSpec, a low-cost battery-powered reader designed to immediately quantify serum bilirubin levels from a small drop of whole blood applied to a lateral flow strip. The simple and affordable BiliSpec system offers a faster and more cost-effective means to detect neonatal jaundice in under-resourced clinics and determine when phototherapy is needed. The goal of this study is to validate the accuracy of the BiliSpec device in measuring bilirubin levels in neonates relative to the laboratory spectrophotometric bilirubinometer and transcutaneous bilirubinometer measurements.

Official title: Validation of a Low-Cost, Point-of-Care Bilirubin Measurement to Diagnose Neonatal Jaundice and Monitor Phototherapy in Hospitals in Sub-Saharan Africa

Key Details

Gender

All

Age Range

0 Days - 28 Days

Study Type

OBSERVATIONAL

Enrollment

1000

Start Date

2019-08-01

Completion Date

2024-08-31

Last Updated

2024-06-07

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

BiliSpec

BiliSpec will quantitatively measure the bilirubin content of a neonatal blood sample.

Locations (3)

Rice University

Houston, Texas, United States

Queen Elizabeth Central Hospital

Blantyre, Malawi

Kamuzu Central Hospital

Lilongwe, Malawi