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

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ClinicalTrials.gov Identifier: NCT02926131
Recruitment Status : Completed
First Posted : October 6, 2016
Last Update Posted : October 2, 2018
Sponsor:
Collaborator:
Shoklo Malaria Research Unit
Information provided by (Responsible Party):
University of Oxford

Tracking Information
First Submitted Date September 22, 2016
First Posted Date October 6, 2016
Last Update Posted Date October 2, 2018
Actual Study Start Date January 25, 2017
Actual Primary Completion Date December 11, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 4, 2016)
  • 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.
  • 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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02926131 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: October 4, 2016)
  • 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.
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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.
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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Blood
Sampling Method Non-Probability Sample
Study Population Infant seen in WPA clinic during the neonatal period (birth to 28 days of life).
Condition
  • Jaundice
  • Serum Bilirubin
Intervention 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
Study Groups/Cohorts Infants
Infants requiring serum bilirubin (SBR) measurement seen in Wang Pha clinic (WPA) clinic.
Intervention: Other: Blood sampling
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 4, 2016)
180
Original Estimated Enrollment Same as current
Actual Study Completion Date December 11, 2017
Actual Primary Completion Date December 11, 2017   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages up to 28 Days   (Child)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Thailand
Removed Location Countries  
 
Administrative Information
NCT Number NCT02926131
Other Study ID Numbers SMRU1606
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University of Oxford
Study Sponsor University of Oxford
Collaborators Shoklo Malaria Research Unit
Investigators
Principal Investigator: Professor Rose McGready, MD Shoklo Malaria Research Unit (SMRU)
PRS Account University of Oxford
Verification Date July 2018