A Study to Evaluate a New Jaundice Stick Test (Bilistick)
Status
Conditions
Treatments
Details and patient eligibility
About
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.
Full description
Study procedure:
- 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.
- 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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Written or thumb print for informed consent from the parent
- Infant born ≥ 35 weeks of gestational age
- Infant who needs a routine SBR measurement
- Infant in stable clinical condition prior to SBR measurement confirmed by the trained nurses
Exclusion criteria
The participant will not be enrolled in the study if ANY of the following applies:
- Infant who already had 1 SBR measurement done with the Bilistick system
- Last haematocrit measurement > 65% or no previous haematocrit measurement
Trial design
180 participants in 1 patient group
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal