Validation of a Jaundice Diagnostic and Monitoring Device for Low-Resource Settings
Status unconfirmed
Conditions studied: Hyperbilirubinemia, Neonatal, Jaundice, Neonatal
In brief
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.
Key facts
- Study ID
- NCT03866213
- Run by
- William Marsh Rice University
- People needed
- 1000
- Starts
- 2019-08-01
- Expected to finish
- 2024-08-31
- Last updated by the study team
- 2024-06-07
Who can join
Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Queen Elizabeth Central Hospital — Blantyre, Malawi (enrolling)
- Kamuzu Central Hospital — Lilongwe, Malawi (enrolling)
- Rice University — Houston, Texas, United States
Full record on ClinicalTrials.gov
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