Neonatal ScreeningNCT06058910
Bilistick Point-of-care System 2.0 Bilirubin Validation
An observational study of Neonatal Screening and Kernicterus, run by Kettering Health Network at 1 site in United States.
Trial summary
This is a validation study involving the Bilistick System 2.0 point-of-care bilirubin measuring device. The validation will be conducted by comparing bilirubin measurements utilizing the standard-of-care blood sample collected for both a diagnostic reference device and Bilistick System 2.0 point-of-care device. Read more about this study
- Who is it for?
- Ages Up to 2 weeksHealthy volunteers can take part
- Conditions the study is for
- Neonatal Screening, Kernicterus, Newborn Jaundice
- What is being tested?
- Bilistick System 2.0 point-of-care testing device
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2024to 9 Sep 2024
- 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 Up to 2 weeks
- All sexes
- Healthy volunteers accepted
- Child
Study population: This study will include newborn pediatric patients under 2-weeks of age who are necessary to conduct this study and are representative of the target population for use with this device.
Who may be able to join
- Participant is <2-weeks of age
- Participant is inpatient hospital status
- Participant undergoing routine blood sample collection for total serum bilirubin
Who cannot join
- Parent or legal guardian of participant is Non-English speaking or reading
- Parent or legal guardian of participant unable to give informed consent/parental permission
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bilistick Point-of-care System 2.0 Bilirubin Validation Utilizing Blood Samples Collected in Pediatric Patients
This is a validation study involving the Bilistick System 2.0 point-of-care bilirubin measuring device. The validation will be conducted by comparing bilirubin measurements utilizing the standard-of-care blood sample collected for both a diagnostic reference device and Bilistick System 2.0 point-of-care device. Whole blood samples collected from male or female newborns (<2-weeks of age) born at a Kettering Health Network facility to obtain a total of 80 valid comparison pairs between the reference device and the Bilistick System 2.0 point-of-care device with current laboratory standards.
Read the detailed description
The investigators propose a prospective diagnostic validation study comparing total bilirubin values measured under the reference clinical methodology to the point-of-care Bilistick System 2.0 testing device. During the routine standard-of-care whole blood sample collection (0.5 milliliters whole blood draw) for bilirubin assessments under reference clinical methodology, an additional 0.035 milliliters of whole blood will be collected (not to exceed more than 2 sample collections per week) for measurement in the point-of-care Bilistick System 2.0. The resulting Bilistick System 2.0 data will be recorded, but will not be entered in the patients' electronic medical records or used for any diagnostic or medical decision purposes.
Whole blood samples collected from male or female newborns (<2-weeks of age) born at a Kettering Health Network facility to obtain a total of 80 valid comparison pairs between the reference device and the Bilistick System 2.0 point-of-care device will be included on study.
Consent forms will be Institutional Review Board (IRB)-approved and the parent or legal guardian of the participant will be asked to read the document. The investigator or delegated study staff will explain the research study to the parent or legal guardian of the participant and answer any questions that may arise. A verbal explanation will be provided to allow for the comprehension of the purposes, procedures, and potential risks of the study and rights of the research participant. The parent or legal guardian of the participant will be informed that participation is voluntary, they can withdraw at any time. Sufficient opportunity will be provided to carefully review the written consent form and ask questions prior to signing. The parent or legal guardian of the participant will sign the informed consent document prior to any procedures being done specifically for the study.
Since this study uses blood collected during an existing standard of care blood collection (i.e., there will be NO separate research-specific heel stick) this study poses no additional risk and parental permission will be required by only one parent.
- Being tested
- Bilistick System 2.0 point-of-care testing device
- Medical subject headings
- Kernicterus, Jaundice, Neonatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilistick System 2.0 point-of-care testing deviceDiagnostic test
Also called Bilistick point-of-care testing device
The routine standard-of-care blood sample collection involves a 0.5 milliliter whole blood draw by the heel stick method for bilirubin assessments under current reference clinical methodology for total bilirubin. An additional 0.035 milliliter of whole blood will be collected for measurement in the point-of-care Bilistick System 2.0 (Bilistick point-of-care testing device). The resulting Bilistick System 2.0 data (i.e., total bilirubin) will be recorded, but will not be entered into the patients' electronic medical records or used for any diagnostic or medical decision purposes.
| Study group | Role | What they receive |
|---|---|---|
| Newborn | This study will include newborn pediatric patients under 2-weeks of age who are necessary to conduct this study and are representative of the target population for use with this device. Receives: Diagnostic Test: Bilistick System 2.0 point-of-care testing device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bilistick Total Bilirubin
Measurement of total bilirubin (milligram/deciliter) using the Bilistick 2.0 point-of-care system
Measured: birth through 2-weeks of age
Reference Clinical Total Bilirubin
Measurement of total bilirubin (milligram/deciliter) using standard laboratory clinical instrument sample analysis
Measured: birth through 2-weeks of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start1 Feb 2024
- Primary completion16 Jun 2024
- Study completion9 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal ScreeningStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kettering Health Network
- Sponsor type
- University, hospital or other
- Collaborators
- Bilimetrix s.r.l.
- Responsible party
- Principal investigator, Jonathan Toot, Kettering Health Network
- Investigators
- Jonathan D Toot, MD, Principal investigator, Kettering Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06058910
- Sponsor's protocol ID
- KHN-2023-109
- Status last verified
- Mar 2025
- First submitted
- 22 Sep 2023
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bilistick Point-of-care System 2.0 Bilirubin Validation Utilizing Blood Samples Collected in Pediatric Patients
- ClinicalTrials.gov ID
- NCT06058910
- Acronym / sponsor ID
- KHN-2023-109
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Kettering Health NetworkUniversity, hospital or other
- Collaborators
- Bilimetrix s.r.l.
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 16 Jun 2024 (actual)
- Study completion
- 9 Sep 2024 (actual)
- First posted
- 28 Sep 2023 (actual)
- 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 a validation study involving the Bilistick System 2.0 point-of-care bilirubin measuring device. The validation will be conducted by comparing bilirubin measurements utilizing the standard-of-care blood sample collected for both a diagnostic reference device and Bilistick System 2.0 point-of-care device. Whole blood samples collected from male or female newborns (<2-weeks of age) born at a Kettering Health Network facility to obtain a total of 80 valid comparison pairs between the reference device and the Bilistick System 2.0 point-of-care device with current laboratory standards.
Detailed description
The investigators propose a prospective diagnostic validation study comparing total bilirubin values measured under the reference clinical methodology to the point-of-care Bilistick System 2.0 testing device. During the routine standard-of-care whole blood sample collection (0.5 milliliters whole blood draw) for bilirubin assessments under reference clinical methodology, an additional 0.035 milliliters of whole blood will be collected (not to exceed more than 2 sample collections per week) for measurement in the point-of-care Bilistick System 2.0. The resulting Bilistick System 2.0 data will be recorded, but will not be entered in the patients' electronic medical records or used for any diagnostic or medical decision purposes.
Whole blood samples collected from male or female newborns (<2-weeks of age) born at a Kettering Health Network facility to obtain a total of 80 valid comparison pairs between the reference device and the Bilistick System 2.0 point-of-care device will be included on study.
Consent forms will be Institutional Review Board (IRB)-approved and the parent or legal guardian of the participant will be asked to read the document. The investigator or delegated study staff will explain the research study to the parent or legal guardian of the participant and answer any questions that may arise. A verbal explanation will be provided to allow for the comprehension of the purposes, procedures, and potential risks of the study and rights of the research participant. The parent or legal guardian of the participant will be informed that participation is voluntary, they can withdraw at any time. Sufficient opportunity will be provided to carefully review the written consent form and ask questions prior to signing. The parent or legal guardian of the participant will sign the informed consent document prior to any procedures being done specifically for the study.
Since this study uses blood collected during an existing standard of care blood collection (i.e., there will be NO separate research-specific heel stick) this study poses no additional risk and parental permission will be required by only one parent.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Newborn | – | Diagnostic Test: Bilistick System 2.0 point-of-care testing deviceThis study will include newborn pediatric patients under 2-weeks of age who are necessary to conduct this study and are representative of the target population for use with this device. |
Who may qualify
- Ages
- Up to 2 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- This study will include newborn pediatric patients under 2-weeks of age who are necessary to conduct this study and are representative of the target population for use with this device.
Key inclusion criteria (3 listed)
- Participant is <2-weeks of age
- Participant is inpatient hospital status
- Participant undergoing routine blood sample collection for total serum bilirubin
Key exclusion criteria (2 listed)
- Parent or legal guardian of participant is Non-English speaking or reading
- Parent or legal guardian of participant unable to give informed consent/parental permission
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 |
|---|---|---|
| Bilistick System 2.0 point-of-care testing deviceAlso: Bilistick point-of-care testing deviceThe routine standard-of-care blood sample collection involves a 0.5 milliliter whole blood draw by the heel stick method for bilirubin assessments under current reference clinical methodology for total bilirubin. An additional 0.035 milliliter of whole blood will be collected for measurement in the point-of-care Bilistick System 2.0 (Bilistick point-of-care testing device). The resulting Bilistick System 2.0 data (i.e., total bilirubin) will be recorded, but will not be entered into the patients' electronic medical records or used for any diagnostic or medical decision purposes. | Diagnostic test | Newborn |
Primary outcome
Bilistick Total Bilirubin
Time frame: birth through 2-weeks of age
Measurement of total bilirubin (milligram/deciliter) using the Bilistick 2.0 point-of-care system
Reference Clinical Total Bilirubin
Time frame: birth through 2-weeks of age
Measurement of total bilirubin (milligram/deciliter) using standard laboratory clinical instrument sample analysis
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 13 Mar 2025.
- Individual participant dataSharing planned: No
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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.
Jonathan D Toot, MD principal investigator
Kettering Health
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 Neonatal Screening and Kernicterus, run by Kettering Health Network at 1 site in United States.
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 3 inclusion and 2 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 13 Mar 2025. 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 United States. 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?
Bilistick Total Bilirubin (time frame: birth through 2-weeks of age). 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 13 Mar 2025.