Jaundice, NeonatalNCT02612207
Point-of-Care System for Determination of Bilirubin Capacity in Neonates
An observational study of Jaundice, Neonatal and Hyperbilirubinemia, run by Stanford University at 2 sites in United States.
Trial summary
The aims of this observational bench project are to validate the performance of the miniaturized and modernized hematofluorometer that measures bilirubin capacity into a product and is suitable for operation in various point of care environments w in the management of preterm neonates. Read more about this study
- Who is it for?
- Ages 6 hours to 14 daysHealthy volunteers can take part
- Conditions the study is for
- Jaundice, Neonatal, Hyperbilirubinemia, Bilirubin-Induced Neurological Dysfunction (BIND)
- What is being tested?
- Bilirubin Binding Capacity by Hematofluorometry Validation
- Type of treatment
- Medical device
- How many people
- 161 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Aug 2015to 31 Aug 2018
- 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 6 hours to 14 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: The study population will consist of preterm (≥ 24 wks GA, BW≥500g) as well as sick or unstable late-term newborns (infants ≥ 35 wks GA, BW≥2500g).
Who may be able to join
None listed.
Who cannot join
- None.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
AVIV Biomedical, Inc.
Lakewood, New Jersey, 08701
Lucile-Packard Children's Hospital at Stanford
Stanford, California, 94305
About this study
Official title: Validation of Bilirubin Binding Capacity (BBC) Using AVIV Device
The aims of this observational bench project are to validate the performance of the miniaturized and modernized hematofluorometer that measures bilirubin capacity into a product and is suitable for operation in various point of care environments w in the management of preterm neonates.
Read the detailed description
The status of bilirubin binding to albumin (Alb) is central to personalized management of unconjugated newborn hyperbilirubinemia, especially those at risk of bilirubin-induced neurologic dysfunction (BIND) (1). Our objectives were to validate the Aviv Bili-4 Hematofluorometer in the context of its usefulness and ease of use based on ad hoc clinical studies and surveys of end-users. In addition, we continued our efforts to validate the Bili-4 device in order to facilitate Aviv, Inc. in their development of claims of the most appropriate use of bilirubin binding capacity (BBC) information in the management of neonates. Neonatal blood samples were obtained from newborns born at Stanford University's LPCH with gestational ages (GA) ranging from 22-40 wks. Total bilirubin (TB), Alb and apparent serum unbound bilirubin (UB) concentrations were measured or calculated. Ratios of bound bilirubin (BB) to reserve Alb binding capacity for bilirubin (RABC) were also determined. Bilirubin binding capacity (BBC) by hematofluorometry (Hmf) was compared to the calculated BBC (or 8.8 × Alb) using Alb levels as measured by the clinical laboratory. We report the progress of this inquiry at the Stanford University (1).
- Being tested
- Bilirubin Binding Capacity by Hematofluorometry Validation
- Keywords
- Bilirubin Binding Capacity Preterm Neonates and Jaundice
- Medical subject headings
- Jaundice, Neonatal, Hyperbilirubinemia, Jaundice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilirubin Binding Capacity by Hematofluorometry ValidationDevice
Observation study
What is being measured
The primary outcome is the main question the study is designed to answer.
Bilirubin Binding Capacity (BBC) on healthy and at-risk infants for impaired binding capacity by hematofluorometery assay
To define normative data (mean, median, range, inter-quartile ranges) among these deemed healthy infants (including those who are at- risk) for increased vulnerability to impaired binding soon after birth
Measured: <14 days of life
Secondary outcomes (1)
Natural history of BBC and stratification of those at risk of disordered bilirubin binding
To delineate the prospective natural history of BBC and stratify those at most or least likely at risk of impaired bilirubin binding
Measured: <14 days of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2015 (estimated)
- Study start1 Aug 2015
- Primary completion31 Aug 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Jaundice, NeonatalStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Aviv Biomedical, Inc.
- Responsible party
- Sponsor
- Investigators
- Vinod K Bhutani, MD, Principal investigator, PI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02612207
- Sponsor's protocol ID
- IRB-24465
- Status last verified
- Sep 2021
- First submitted
- 5 Nov 2015
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lamola AA, Bhutani VK, Du L, Castillo Cuadrado M, Chen L, Shen Z, Wong RJ, Stevenson DK. Neonatal bilirubin binding capacity discerns risk of neurological dysfunction. Pediatr Res. 2015 Feb;77(2):334-9. doi: 10.1038/pr.2014.191. Epub 2014 Nov 24.
PubMed 25420178
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Bilirubin Binding Capacity (BBC) Using AVIV Device
- ClinicalTrials.gov ID
- NCT02612207
- Acronym / sponsor ID
- IRB-24465
- Keywords
- Bilirubin Binding Capacity Preterm Neonates and Jaundice
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Aviv Biomedical, Inc.
- Study start
- 1 Aug 2015 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 23 Nov 2015 (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.
The aims of this observational bench project are to validate the performance of the miniaturized and modernized hematofluorometer that measures bilirubin capacity into a product and is suitable for operation in various point of care environments w in the management of preterm neonates.
Detailed description
The status of bilirubin binding to albumin (Alb) is central to personalized management of unconjugated newborn hyperbilirubinemia, especially those at risk of bilirubin-induced neurologic dysfunction (BIND) (1). Our objectives were to validate the Aviv Bili-4 Hematofluorometer in the context of its usefulness and ease of use based on ad hoc clinical studies and surveys of end-users. In addition, we continued our efforts to validate the Bili-4 device in order to facilitate Aviv, Inc. in their development of claims of the most appropriate use of bilirubin binding capacity (BBC) information in the management of neonates. Neonatal blood samples were obtained from newborns born at Stanford University's LPCH with gestational ages (GA) ranging from 22-40 wks. Total bilirubin (TB), Alb and apparent serum unbound bilirubin (UB) concentrations were measured or calculated. Ratios of bound bilirubin (BB) to reserve Alb binding capacity for bilirubin (RABC) were also determined. Bilirubin binding capacity (BBC) by hematofluorometry (Hmf) was compared to the calculated BBC (or 8.8 × Alb) using Alb levels as measured by the clinical laboratory. We report the progress of this inquiry at the Stanford University (1).
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 hours to 14 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The study population will consist of preterm (≥ 24 wks GA, BW≥500g) as well as sick or unstable late-term newborns (infants ≥ 35 wks GA, BW≥2500g).
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- None.
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 |
|---|---|---|
| Bilirubin Binding Capacity by Hematofluorometry ValidationObservation study | Device | – |
Primary outcome
Bilirubin Binding Capacity (BBC) on healthy and at-risk infants for impaired binding capacity by hematofluorometery assay
Time frame: <14 days of life
To define normative data (mean, median, range, inter-quartile ranges) among these deemed healthy infants (including those who are at- risk) for increased vulnerability to impaired binding soon after birth
1 secondary outcome
Natural history of BBC and stratification of those at risk of disordered bilirubin binding
Time frame: <14 days of life
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 28 Sep 2021.
- Results publication: PubMed 25420178Lamola AA, Bhutani VK, Du L, Castillo Cuadrado M, Chen L, Shen Z, Wong RJ, Stevenson DK. Neonatal bilirubin binding capacity discerns risk of neurological dysfunction. Pediatr Res. 2015 Feb;77(2):334-9. doi: 10.1038/pr.2014.191. Epub 2014 Nov 24.
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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.
Vinod K Bhutani, MD principal investigator
PI
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Jaundice, Neonatal and Hyperbilirubinemia, run by Stanford University at 2 sites 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 0 inclusion and 1 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 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Bilirubin Binding Capacity (BBC) on healthy and at-risk infants for impaired binding capacity by hematofluorometery assay (time frame: <14 days of life). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02612207, which also lists 1 linked publication.
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 28 Sep 2021.