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A Study to Evaluate a New Jaundice Stick Test — Bilistick  

Jaundice Clinical Trial

Official title:
Field Evaluation of a Point-Of-Care Test for Serum Bilirubin Levels in Infants Born in a Tropical Limited-resource Setting.

Clinical Trial Summary

This is an observational prospective study. The main purpose is to evaluate the stability of the Bilistick system in a humid and hot climate compared to the quantitative test for serum bilirubin (SBR) measurement currently used, the BR-501 total bilirubin meter, kept in a controlled environment.

The secondary aim is to assess the operational feasibility of the Bilistick system in a tropical limited-resource setting, when used by locally trained nurses.

Clinical Trial Description

Study procedure:

1. SBR will be measured in parallel with two tests during three distinct seasons. (Cold, hot, rainy). The Blood is from an extra capillary sample taken from a single heel prick done for routine SBR) BR-501 total bilirubin meter, the quantitative test for SBR currently used, will be kept in a controlled environment while the new bilirubin test (Bilistick system) will be exposed to tropical conditions.

2. Trained nurses will use the Bilistick system observed by a qualified laboratory technician; Usability of the Bilistick system by the trained nurses will be evaluated via a 5-point Likert scale questionnaire and focus groups discussions. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02926131
Study type Observational
Source University of Oxford
Contact
Status Completed
Phase
Start date January 25, 2017
Completion date December 11, 2017
View Details
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