A Study to Evaluate a New Jaundice Stick Test

NCT02926131 | Completed

• 1 other identifier: SMRU1606
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Jaundice; Serum Bilirubin

Keywords

stick test

Outcome Measures

Primary Outcomes (2)

• Comparison of the agreement of serum bilirubin measurement between the two tests in three different seasons

  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.

  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 Outcomes (2)

• Evaluation of the usability of the Bilistick system using a 5-point likert scale questionnaire and a focus group discussions

  18 months

• Perception by the trained nurses of the Bilistick system usability with a focus group discussion (FGD).

  18 months

Study Arms (1)

Infants

Infants requiring serum bilirubin (SBR) measurement seen in Wang Pha clinic (WPA) clinic.

Other: Blood sampling

Interventions

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

Infants

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Infant seen in WPA clinic during the neonatal period (birth to 28 days of life).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oxford: lead
• Shoklo Malaria Research Unit: collaborator

Study Sites (1)

Shoklo Malaria Research Unit (SMRU)

Mae Sot, Changwat Tak, 63110, Thailand

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood

MeSH Terms

Conditions

Jaundice

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Professor Rose McGready, MD

  Shoklo Malaria Research Unit (SMRU)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2016
• First Posted: October 6, 2016
• Study Start: January 25, 2017
• Primary Completion: December 11, 2017
• Study Completion: December 11, 2017
• Last Updated: October 2, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)