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

Conditions

• Hyperbilirubinemia, Neonatal
• Jaundice, Neonatal

Eligibility Criteria

Sex

ALL

Age

0 Days - 28 Days

Healthy Volunteers

Not accepted

Interventions

• BiliSpec — DIAGNOSTIC_TEST
  BiliSpec will quantitatively measure the bilirubin content of a neonatal blood sample.

Study Details

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.

Key Dates

Start date

Aug 1, 2019

Status verified

Jun 2024

Primary completion

Aug 31, 2024

Completion

Aug 31, 2024

Study Design

Enrollment

1,000 participants (estimated)

Arms

• Arm: 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.

Primary Outcome Measure

Device Accuracy [ Time Frame: Total duration of hospital stay while inclusion criteria are met (<10 minutes per sample) ]

Central Contacts

• Rebecca Massey, MPH, BSN, RN
  713-348-6574
  [email protected]
• Meaghan Bond, PhD
  [email protected]

Locations (1)

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