A Study to Evaluate a New Jaundice Stick Test

Completed

• Conditions: Serum Bilirubin; Jaundice
• Interventions: Other: Blood sampling

• Registration Number: NCT02926131
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-09-22
• Study First Submitted QC: 2016-10-04
• Study First Posted: 2016-10-06
• Study Start: 2017-01-25
• Primary Completion: 2017-12-11
• Study Completion: 2017-12-11
• Status Verified: 2018-07
• Last Update Submitted: 2018-10-01
• Last Update Posted: 2018-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Infants	Blood sampling	Infants requiring serum bilirubin (SBR) measurement seen in Wang Pha clinic (WPA) clinic.

Primary Outcome Measures

Name	Time	Method
Comparison of the agreement of serum bilirubin measurement between the two tests in three different seasons	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.	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

Name	Time	Method
Evaluation of the usability of the Bilistick system using a 5-point likert scale questionnaire and a focus group discussions	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).	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.

Trial Locations

Locations (1)

Shoklo Malaria Research Unit (SMRU); 🇹🇭 Mae Sot, Tak, Thailand