RecruitingNCT03866213

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

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


Sponsor

William Marsh Rice University

Enrollment

1,000 participants

Start Date

Aug 1, 2019

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 0 DaysMax Age: 28 Days

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying BiliSpec for people with hyperbilirubinemia, neonatal and jaundice, neonatal. The study is currently recruiting participants at 3 locations. People eligible for this study include aged 0 Days to 28 Days.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTBiliSpec

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

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NCT03866213


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