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| Name | Class |
|---|---|
| Shoklo Malaria Research Unit | OTHER |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infants | Infants requiring serum bilirubin (SBR) measurement seen in Wang Pha clinic (WPA) clinic. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sampling | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the agreement of serum bilirubin measurement between the two tests in three different seasons | 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. | 18 months |
| Within each season, evaluation of the impact of temporal variation on the agreement of serum bilirubin measurement between the two tests. | 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. | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the usability of the Bilistick system using a 5-point likert scale questionnaire and a focus group discussions | 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. |
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Inclusion Criteria:
Exclusion Criteria:
The participant will not be enrolled in the study if ANY of the following applies:
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Infant seen in WPA clinic during the neonatal period (birth to 28 days of life).
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| Name | Affiliation | Role |
|---|---|---|
| Professor Rose McGready, MD | Shoklo Malaria Research Unit (SMRU) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shoklo Malaria Research Unit (SMRU) | Mae Sot | Changwat Tak | 63110 | Thailand |
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| ID | Term |
|---|---|
| D007565 | Jaundice |
| ID | Term |
|---|---|
| D006932 | Hyperbilirubinemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Blood
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| 18 months |
| Perception by the trained nurses of the Bilistick system usability with a focus group discussion (FGD). | 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. | 18 months |
| D012816 | Signs and Symptoms |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |