Validation of a Jaundice Diagnostic and Monitoring Device for Low-Resource Settings
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-28
SponsorWilliam Marsh Rice University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Patients currently being treated at Queen Elizabeth Central Hospital or Kamuzu Central Hospital in the neonatal ward, who are less than 28 days old (neonate), and deemed to be at risk for jaundice or the patient is undergoing blue light phototherapy for treatment of jaundice.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
BiliSpec
Diagnostic testBiliSpec will quantitatively measure the bilirubin content of a neonatal blood sample.
Treatment groups
1,000 Participants
are divided into 1 treatment groupGroup A: Quantitative Measurement of Bilirubin1 intervention
Trial outcomes
Primary outcomes
1
Device Accuracy
Bilirubin content measured by the BiliSpec device compared against the Reichert UNISTAT laboratory spectophotometric bilirubinometer as well as a transcutaneous bilirubinometer.
Time frame
Total duration of hospital stay while inclusion criteria are met (<10 minutes per sample)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
William Marsh Rice University
Lead sponsor
Kamuzu University of Health Sciences
Collaborator
Lagos University Teaching Hospital (LUTH)
Collaborator
Source ClinicalTrials.gov