Point-of-Care System for Determination of Bilirubin Capacity in Neonates
Validation of Bilirubin Binding Capacity (BBC) Using AVIV Device
1 other identifier
observational
161
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2015
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 5, 2015
CompletedFirst Posted
Study publicly available on registry
November 23, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2018
CompletedSeptember 28, 2021
September 1, 2021
3.1 years
November 5, 2015
September 24, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
<14 days of life
Secondary Outcomes (1)
Natural history of BBC and stratification of those at risk of disordered bilirubin binding
<14 days of life
Interventions
Observation study
Eligibility Criteria
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).
You may qualify if:
- Parental informed consent
- Male and female newborns with a GA ≥ 24 wks with a birthweight ≥ 500 g as well as sick or unstable late preterm newborns infants with GA ≥ 35 wks with a birthweight ≥ 2500 g.
- Enrollment at age less than 14 days and more than 6h
You may not qualify if:
- None.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stanford Universitylead
- Aviv Biomedical, Inc.collaborator
Study Sites (2)
Lucile-Packard Children's Hospital at Stanford
Stanford, California, 94305, United States
AVIV Biomedical, Inc.
Lakewood, New Jersey, 08701, United States
Related Publications (1)
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.
PMID: 25420178RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vinod K Bhutani, MD
PI
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 5, 2015
First Posted
November 23, 2015
Study Start
August 1, 2015
Primary Completion
August 31, 2018
Study Completion
August 31, 2018
Last Updated
September 28, 2021
Record last verified: 2021-09