Status:
RECRUITING
Validation of a Jaundice Diagnostic and Monitoring Device for Low-Resource Settings
Lead Sponsor:
William Marsh Rice University
Collaborating Sponsors:
Kamuzu University of Health Sciences
Lagos University Teaching Hospital (LUTH)
Conditions:
Hyperbilirubinemia, Neonatal
Jaundice, Neonatal
Eligibility:
All Genders
Up to 28 years
Brief 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 b...
Detailed Description
This study will validate the accuracy of the BiliSpec device in measuring bilirubin levels in neonates relative to a laboratory spectrophotometric bilirubinometer (Reichert UNISTAT® Bilirubinometer) a...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 31 2024
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT03866213
Start Date
August 1 2019
End Date
August 31 2024
Last Update
June 7 2024
Active Locations (3)
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1
Rice University
Houston, Texas, United States, 77030
2
Queen Elizabeth Central Hospital
Blantyre, Malawi
3
Kamuzu Central Hospital
Lilongwe, Malawi, 30700