JaundiceBilistickNCT02926131
A Study to Evaluate a New Jaundice Stick Test
An observational study of Jaundice and Serum Bilirubin, run by University of Oxford at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Jaundice, Serum Bilirubin
- What is being tested?
- Blood sampling
- How many people
- 180 participants
- Where
- 1 siteThailand
- Study dates
- 25 Jan 2017to 11 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 28 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: Infant seen in WPA clinic during the neonatal period (birth to 28 days of life).
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Shoklo Malaria Research Unit (SMRU)
Mae Sot, Changwat Tak, 63110
About this study
Official title: Field Evaluation of a Point-Of-Care Test for Serum Bilirubin Levels in Infants Born in a Tropical Limited-resource Setting.
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.
Read the detailed description
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.
- Conditions
- Jaundice, Serum Bilirubin
- Being tested
- Blood sampling
- Keywords
- stick test
- Medical subject headings
- Jaundice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingOther
- 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 group | Role | What they receive |
|---|---|---|
| Infants | Infants requiring serum bilirubin (SBR) measurement seen in Wang Pha clinic (WPA) clinic. Receives: Other: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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.
Measured: 18 months
Perception by the trained nurses of the Bilistick system usability with a focus group discussion (FGD).
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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2016 (estimated)
- Study start25 Jan 2017
- Primary completion11 Dec 2017
- Study completion11 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for JaundiceStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Shoklo Malaria Research Unit
- Responsible party
- Sponsor
- Investigators
- Professor Rose McGready, MD, Principal investigator, Shoklo Malaria Research Unit (SMRU)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02926131
- Sponsor's protocol ID
- SMRU1606
- Acronym
- Bilistick
- Status last verified
- Jul 2018
- First submitted
- 22 Sep 2016
- Last updated
- 2 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Field Evaluation of a Point-Of-Care Test for Serum Bilirubin Levels in Infants Born in a Tropical Limited-resource Setting.
- ClinicalTrials.gov ID
- NCT02926131
- Acronym / sponsor ID
- Bilistick / SMRU1606
- Conditions
- Jaundice, Serum Bilirubin
- Keywords
- stick test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Shoklo Malaria Research Unit
- Study start
- 25 Jan 2017 (actual)
- Primary completion
- 11 Dec 2017 (actual)
- Study completion
- 11 Dec 2017 (actual)
- First posted
- 6 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infants | – | Other: Blood samplingInfants requiring serum bilirubin (SBR) measurement seen in Wang Pha clinic (WPA) clinic. |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Infant seen in WPA clinic during the neonatal period (birth to 28 days of life).
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Infant who already had 1 SBR measurement done with the Bilistick system
- Last haematocrit measurement > 65% or no previous haematocrit measurement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | Infants |
Primary outcome
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.
2 secondary outcomes
Evaluation of the usability of the Bilistick system using a 5-point likert scale questionnaire and a focus group discussions
Time frame: 18 months
Perception by the trained nurses of the Bilistick system usability with a focus group discussion (FGD).
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2018.
- Individual participant dataSharing planned: No
Related trials for Jaundice
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Newborn Abdominal Massage to Prevent Hyperbilirubinemia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Professor Rose McGready, MD principal investigator
Shoklo Malaria Research Unit (SMRU)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Jaundice and Serum Bilirubin, run by University of Oxford at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the agreement of serum bilirubin measurement between the two tests in three different seasons (time frame: 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2018.