Actively Recruiting

Age: 0Days - 28Days
All Genders
NCT03866213

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

Age: 0Days - 28Days
All Genders

Eligibility Criteria

Eligible

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.
Not Eligible

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

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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

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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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