Validation of a Low-Cost, Point-of-Care Bilirubin Measurement to Diagnose Neonatal Jaundice and Monitor Phototherapy in Hospitals in Sub-Saharan Africa

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Diagnostic test
Study Type: Observational
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 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
Participation Requirements
Sex: All
Maximum Age: 28 days
Healthy Volunteers: f
View:

• 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.

Locations
United States
Texas
Rice University
ACTIVE_NOT_RECRUITING
Houston
Other Locations
Malawi
Queen Elizabeth Central Hospital
RECRUITING
Blantyre
Kamuzu Central Hospital
RECRUITING
Lilongwe
Contact Information
Primary
Rebecca Massey, MPH, BSN, RN
rebecca.elias@rice.edu
713-348-6574
Backup
Meaghan Bond, PhD
meaghan.mc.bond@rice.edu
Time Frame
Start Date: 2019-08-01
Estimated Completion Date: 2024-08-31
Participants
Target number of participants: 1000
Treatments
Quantitative Measurement of Bilirubin
Bilirubin content of the neonate will be measured by the following: BiliSpec, laboratory spectophotometric bilirubinometer (Reichert UNISTAT), and transcutaneous bilirubinometer. The infant may or may not be receiving phototherapy treatment at the time of sample measurement.
Sponsors
Leads: William Marsh Rice University
Collaborators: Lagos University Teaching Hospital (LUTH), Kamuzu University of Health Sciences

This content was sourced from clinicaltrials.gov