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Point-of-Care System for Determination of Bilirubin Capacity in Neonates

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ClinicalTrials.gov Identifier: NCT02612207
Recruitment Status : Recruiting
First Posted : November 23, 2015
Last Update Posted : April 17, 2017
Sponsor:
Collaborators:
Albert Einstein Healthcare Network
University of Pittsburgh
The University of Texas Health Science Center, Houston
Beth Israel Deaconess Medical Center
Aviv Biomedical, Inc.
Information provided by (Responsible Party):
Vinod K. Bhutani, Stanford University

Brief Summary:
The aims of this 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 when encountering confounding direct bilirubin, to complete the development of easy to use sample handling disposables, and to verify the performance of the system for samples from a specified population of neonates.

Condition or disease Intervention/treatment
Jaundice, Neonatal Hyperbilirubinemia Bilirubin-Induced Neurological Dysfunction (BIND) Device: Bilirubin Binding Capacity by hematofluorometry

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : August 2015
Estimated Primary Completion Date : December 2017



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Natural history of BBC and stratification of those at risk of disordered bilirubin binding [ Time Frame: <14 days of life ]
    o delineate the prospective natural history of BBC and stratify those at most or least likely at risk of impaired bilirubin binding



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Ages Eligible for Study:   up to 14 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The study population will consist of preterm (≥ 28 wks GA, BW≥1000g) as well as sick or unstable late-term newborns (infants ≥ 35 wks GA, BW≥2500g).
Criteria

Inclusion Criteria:

  • Subjects must meet all of the following inclusion criteria to be considered eligible for study enrollment soon after birth or re-admission (for phototherapy):

    • Parental informed consent
    • Male and female newborns with a GA ≥ 28 wks with a birthweight ≥ 1000 g including infants with GA ≥ 35 wks with a birthweight ≥ 2500 g who are clinically deemed at risk.
    • Enrollment at age less than 14 days and more than 6h

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02612207


Locations
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United States, California
Lucile-Packard Children's Hospital at Stanford Recruiting
Stanford, California, United States, 94305
Contact: Vinod K Bhutani, MD    650-723-5711    bhutani@stanford.edu   
Contact: Martin E Castillo Cuadrado, BS    415-531-8778    martinc@stanford.edu   
Principal Investigator: Vinod K Bhutani, MD         
United States, Massachusetts
Beth Israel Deaconess Medical Center Not yet recruiting
Boston, Massachusetts, United States, 02215
Contact: John Zupancic, MD       jzupanci@bidmc.harvard.edu   
Principal Investigator: John Zupancic, MD         
United States, Pennsylvania
Albert Enstein Medical Center Enrolling by invitation
Philadelphia, Pennsylvania, United States, 19141
Magee-Womens' Hospital of University of Pittsburgh Medical Center Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Jon F Watchko, MD    412-641-1834    watcjf@mail.magee.edu   
Principal Investigator: Jon F Watchko, MD         
United States, Texas
University of Texas Medical School at Houston Enrolling by invitation
Houston, Texas, United States, 77030
Sponsors and Collaborators
Stanford University
Albert Einstein Healthcare Network
University of Pittsburgh
The University of Texas Health Science Center, Houston
Beth Israel Deaconess Medical Center
Aviv Biomedical, Inc.

Publications of Results:
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Responsible Party: Vinod K. Bhutani, Neonatologist, Professor of Pediatrics, Stanford University
ClinicalTrials.gov Identifier: NCT02612207     History of Changes
Other Study ID Numbers: IRB-24465
First Posted: November 23, 2015    Key Record Dates
Last Update Posted: April 17, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
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Jaundice
Jaundice, Neonatal
Hyperbilirubinemia
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Hyperbilirubinemia, Neonatal
Infant, Newborn, Diseases
Bilirubin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs