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NCT Number: NCT02926131

A Study to Evaluate a New Jaundice Stick Test

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.

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Key information

Conditions

Jaundice Hyperbilirubinemia Pathologic Processes Pathological Conditions, Signs and Symptoms Serum Bilirubin Signs and Symptoms Skin Manifestations

Age range

1 day–28 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Shoklo Malaria Research Unit (SMRU)

Mae Sot, Changwat Tak, 63110, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sampling

Other
  • 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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Collaborators

  • Shoklo Malaria Research Unit

Registry information

Official study title

Field Evaluation of a Point-Of-Care Test for Serum Bilirubin Levels in Infants Born in a Tropical Limited-resource Setting.

Acronym: Bilistick

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Oct 6, 2016
Registry last updated
Oct 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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