Clinical Research Directory
Browse clinical research sites, groups, and studies.
Validation of a Jaundice Diagnostic and Monitoring Device for Low-Resource Settings
Sponsor: William Marsh Rice University
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
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