- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02926131
A Study to Evaluate a New Jaundice Stick Test (Bilistick)
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 Overview
Detailed 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Tak
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Mae Sot, Tak, Thailand, 63110
- Shoklo Malaria Research Unit (SMRU)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Infants
Infants requiring serum bilirubin (SBR) measurement seen in Wang Pha clinic (WPA) clinic.
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
18 months
|
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.
|
18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
18 months
|
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.
|
18 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Professor Rose McGready, MD, Shoklo Malaria Research Unit (SMRU)
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SMRU1606
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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