Clinical trial NCT02926131: A Study to Evaluate a New Jaundice Stick Test
Official title: Field Evaluation of a Point-Of-Care Test for Serum Bilirubin Levels in Infants Born in a Tropical Limited-resource Setting.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Jaundice
Serum Bilirubin
Keywords: stick test
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: Shoklo Malaria Research Unit
First posted: 2016-10-06
Enrollment: 180
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infant seen in WPA clinic during the neonatal period (birth to 28 days of life).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Comparison of the agreement of serum bilirubin measurement between the two tests in three different seasons
timeFrame: 18 months
measure: Within each season, evaluation of the impact of temporal variation on the agreement of serum bilirubin measurement between the two tests.
timeFrame: 18 months
Secondary outcomes:
measure: Evaluation of the usability of the Bilistick system using a 5-point likert scale questionnaire and a focus group discussions
timeFrame: 18 months
measure: Perception by the trained nurses of the Bilistick system usability with a focus group discussion (FGD).
timeFrame: 18 months
Other outcomes:
Locations:
city: Mae Sot
country: Thailand
facility: Shoklo Malaria Research Unit (SMRU)
state: Tak
Study officials:
affiliation: Shoklo Malaria Research Unit (SMRU)
name: Professor Rose McGready, MD
role: PRINCIPAL_INVESTIGATOR
References: