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

NCT03866213 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2024-06-07

No results posted yet for this study

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.

Conditions

  • Hyperbilirubinemia, Neonatal
  • Jaundice, Neonatal

Interventions

DIAGNOSTIC_TEST

BiliSpec

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

Sponsors & Collaborators

  • Kamuzu University of Health Sciences

    collaborator OTHER

  • Lagos University Teaching Hospital (LUTH)

    collaborator UNKNOWN

  • William Marsh Rice University

    lead OTHER

Principal Investigators

  • Rebecca Richards-Kortum, PhD · William Marsh Rice University

  • Maria Oden, PhD · William Marsh Rice University

  • Queen Dube, MD · Kamuzu University of Health Sciences

  • Msandeni Chiume, MD · Kamuzu University of Health Sciences

Eligibility

Min Age
0 Days
Max Age
28 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-01
Primary Completion
2024-08-31
Completion
2024-08-31

Countries

  • United States
  • Malawi

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03866213 on ClinicalTrials.gov