A Study to Evaluate a New Jaundice Stick Test (Bilistick)
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|ClinicalTrials.gov Identifier: NCT02926131|
Recruitment Status : Completed
First Posted : October 6, 2016
Last Update Posted : October 2, 2018
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.
|Condition or disease||Intervention/treatment|
|Jaundice Serum Bilirubin||Other: Blood sampling|
- 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.
|Study Type :||Observational|
|Actual Enrollment :||180 participants|
|Official Title:||Field Evaluation of a Point-Of-Care Test for Serum Bilirubin Levels in Infants Born in a Tropical Limited-resource Setting.|
|Actual Study Start Date :||January 25, 2017|
|Actual Primary Completion Date :||December 11, 2017|
|Actual Study Completion Date :||December 11, 2017|
Infants requiring serum bilirubin (SBR) measurement seen in Wang Pha clinic (WPA) clinic.
Other: Blood sampling
- Comparison of the agreement of serum bilirubin measurement between the two tests in three different seasons [ Time Frame: 18 months ]The main outcome of interest is the potential effect of environmental conditions on the quantitative outcome of the Bilistick System, using BR-501 bilirubin meter machine as a reference. The Bland-Altman analysis will be used to compare the two tests.
- Within each season, evaluation of the impact of temporal variation on the agreement of serum bilirubin measurement between the two tests. [ Time Frame: 18 months ]A linear regression analysis will be done to look for statistically significant effect of exposure time on the difference between the average total bilirubin serum levels of the two tests.
- Evaluation of the usability of the Bilistick system using a 5-point likert scale questionnaire and a focus group discussions [ Time Frame: 18 months ]5-point likert scale questionnaire will be filled individually by the trained nurses at the end of each defined season. Quantitative variables related to the secondary outcomes will be measured with the mean, median and ratio according to the distribution of the variable and compared with appropriated statistical test.
- Perception by the trained nurses of the Bilistick system usability with a focus group discussion (FGD). [ Time Frame: 18 months ]The FGD will be centered around the answers obtained from the questionnaires and the concerns raised by the trained nurses and laboratory technicians during each recruitment period. Qualitative variable from the focus group will be analysed with Nvivo.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02926131
|Shoklo Malaria Research Unit (SMRU)|
|Mae Sot, Tak, Thailand, 63110|
|Principal Investigator:||Professor Rose McGready, MD||Shoklo Malaria Research Unit (SMRU)|