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.
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.
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.
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