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

Description

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.

Conditions

Hyperbilirubinemia, Neonatal, Jaundice, Neonatal

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

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

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

Condition
Hyperbilirubinemia, Neonatal
Intervention / Treatment

-

Contacts and Locations

Houston

Rice University, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * The patient is currently being treated at Queen Elizabeth Central Hospital or Kamuzu Central Hospital in the neonatal ward.
  • * The patient is less than 28 days old (neonate).
  • * The patient is deemed to be at risk for jaundice or the patient is undergoing blue light phototherapy for treatment of jaundice.
  • * The patient's parent or guardian has provided informed consent for their child to participate.
  • * Parent or guardian is unable or unwilling to provide informed consent.
  • * The patient is unable to receive a blood draw/heel stick as determined by their clinician.

Ages Eligible for Study

0 Days to 28 Days

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

William Marsh Rice University,

Rebecca Richards-Kortum, PhD, PRINCIPAL_INVESTIGATOR, William Marsh Rice University

Maria Oden, PhD, PRINCIPAL_INVESTIGATOR, William Marsh Rice University

Queen Dube, MD, PRINCIPAL_INVESTIGATOR, Kamuzu University of Health Sciences

Msandeni Chiume, MD, PRINCIPAL_INVESTIGATOR, Kamuzu University of Health Sciences

Study Record Dates

2024-08-31