Actively Recruiting
Validation of a Jaundice Diagnostic and Monitoring Device for Low-Resource Settings
Led by William Marsh Rice University · Updated on 2024-06-07
1000
Participants Needed
3
Research Sites
265 weeks
Total Duration
On this page
Sponsors
W
William Marsh Rice University
Lead Sponsor
K
Kamuzu University of Health Sciences
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Validation of a Jaundice Diagnostic and Monitoring Device for Low-Resource Settings
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Rice University
Houston, Texas, United States, 77030
Active, Not Recruiting
2
Queen Elizabeth Central Hospital
Blantyre, Malawi
Actively Recruiting
3
Kamuzu Central Hospital
Lilongwe, Malawi, 30700
Actively Recruiting
Research Team
R
Rebecca Massey, MPH, BSN, RN
CONTACT
M
Meaghan Bond, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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