RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2019-08-01
Study Completion:2024-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03866213

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.

Ages Eligible for Study:0 Days to 28 Days
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * The patient is currently being treated at Queen Elizabeth Central Hospital or Kamuzu Central Hospital in the neonatal ward.
  2. * The patient is less than 28 days old (neonate).
  3. * The patient is deemed to be at risk for jaundice or the patient is undergoing blue light phototherapy for treatment of jaundice.
  4. * The patient's parent or guardian has provided informed consent for their child to participate.
  1. * Parent or guardian is unable or unwilling to provide informed consent.
  2. * The patient is unable to receive a blood draw/heel stick as determined by their clinician.

Contacts and Locations

Study Contact

Rebecca Massey, MPH, BSN, RN
CONTACT
713-348-6574
rebecca.elias@rice.edu
Meaghan Bond, PhD
CONTACT
meaghan.mc.bond@rice.edu

Principal Investigator

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 Locations (Sites)

Rice University
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-08-01
Study Completion Date2024-08-31

Study Record Updates

Study Start Date2019-08-01
Study Completion Date2024-08-31

Terms related to this study

Keywords Provided by Researchers

  • Diagnostic
  • Point-of-Care
  • Low-Resource Setting

Additional Relevant MeSH Terms

  • Hyperbilirubinemia, Neonatal
  • Jaundice, Neonatal