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A Study to Evaluate a New Jaundice Stick Test (Bilistick)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02926131
Recruitment Status : Completed
First Posted : October 6, 2016
Last Update Posted : October 2, 2018
Shoklo Malaria Research Unit
Information provided by (Responsible Party):
University of Oxford

Brief Summary:

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

Detailed Description:

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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Study Type : Observational
Actual Enrollment : 180 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Group/Cohort Intervention/treatment
Infants requiring serum bilirubin (SBR) measurement seen in Wang Pha clinic (WPA) clinic.
Other: Blood sampling
  • One full capillary tube (50µl blood) will be used to measure the Hct level and the routine SBR using the BR-501 bilirubin meter machine (non-study procedure).
  • An additional half- filled capillary tube (25µl blood) will be used for the SBR measurement with the Bilistick system

Primary Outcome Measures :
  1. 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.

  2. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Infant seen in WPA clinic during the neonatal period (birth to 28 days of life).

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT02926131

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Shoklo Malaria Research Unit (SMRU)
Mae Sot, Tak, Thailand, 63110
Sponsors and Collaborators
University of Oxford
Shoklo Malaria Research Unit
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Principal Investigator: Professor Rose McGready, MD Shoklo Malaria Research Unit (SMRU)

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Responsible Party: University of Oxford Identifier: NCT02926131     History of Changes
Other Study ID Numbers: SMRU1606
First Posted: October 6, 2016    Key Record Dates
Last Update Posted: October 2, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Oxford:
stick test

Additional relevant MeSH terms:
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Pathologic Processes
Skin Manifestations
Signs and Symptoms
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs