Validation of a Jaundice Diagnostic and Monitoring Device for Low-Resource Settings

Launched by WILLIAM MARSH RICE UNIVERSITY · Mar 5, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a new device called BiliSpec, which is designed to quickly and accurately measure bilirubin levels in newborns. Bilirubin is a substance that can build up in the blood and cause jaundice, a common condition in babies. The BiliSpec device is low-cost and battery-powered, allowing healthcare providers in clinics with fewer resources to test for jaundice using just a small drop of blood. The researchers want to see how well the BiliSpec device works compared to other established methods used in hospitals.

To be eligible for this trial, babies must be less than 28 days old and being treated in the neonatal ward of Queen Elizabeth Central Hospital or Kamuzu Central Hospital. They should either be at risk for jaundice or currently receiving treatment with blue light therapy. Parents or guardians will need to give their permission for their child to participate. If you decide to take part, your baby will have a small blood sample taken for testing, and the results will help doctors know if treatment is necessary. This study aims to make it easier and faster to detect jaundice in newborns, especially in places where resources are limited.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.