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Bilirubin Binding Capacity to Assess Bilirubin Load in Preterm Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02691156
Recruitment Status : Unknown
Verified August 2017 by Vinod K. Bhutani, Stanford University.
Recruitment status was:  Recruiting
First Posted : February 25, 2016
Last Update Posted : October 9, 2017
Smith-Kettlewell Eye Research Institute
Information provided by (Responsible Party):
Vinod K. Bhutani, Stanford University

Brief Summary:
Most preterm newborns are managed by phototherapy to reverse hyperbilirubinemia with the intent to prevent bilirubin neurotoxicity. A threshold-based relationship between a specific total bilirubin level and need for intervention has been elusive. This is most likely due to other biomarkers such as hemolysis, developmental maturation, concurrent illnesses, or even interventions, may impede bilirubin/albumin binding. The over-prescription of phototherapy has impacted clinical and family-centered care, and in the extreme preterm infants, it may have augmented their risk of mortality. Thus, the opportunity to individualize phototherapy in in order to reduce its use is unique. The investigators have assembled a transdisciplinary team to examine critical unanswered questions including the role of bilirubin binding capacity (BBC) of an individual during the first week of life in the context of clinical modifiers and antecedents for a domain of bilirubin-induced neurologic disorders, that includes neuro-anatomical, hearing, visual and developmental processing impairments. In this study, the investigator will evaluate two new innovative nanotechniques to quantify bilirubin load for the first time in the context of a clinical decision algorithm to identify those most at risk for any bilirubin-related neurotoxicity. The investigators anticipate that knowledge gained from this study will lead to ethically testable hypotheses to individualize the prescription of phototherapy.

Condition or disease Intervention/treatment
Bilirubin-induced Neurologic Dysfunction Hyperbilirubinemia Kernicterus Infant, Premature Infant, Low Birth Weight Other: Bilirubin Binding Capacity Other: End-tidal Carbon Monoxide Other: Carboxyhemoglobin

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Bilirubin Binding Capacity to Assess Bilirubin Load in Preterm Infants
Study Start Date : December 2015
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : December 2017

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Group/Cohort Intervention/treatment
Premature Infants
Premature infants GA 24 to ≤34 wks at risk for hyperbilirubinemia will have BBC, ETCOc, and COHbc measured during 0-7 days of life.
Other: Bilirubin Binding Capacity
Laboratory assay of bilirubin binding capacity
Other Name: BBC

Other: End-tidal Carbon Monoxide
Noninvasive bedside test to measure exhaled end-tidal carbon monoxide levels for the detection of hemolysis
Other Name: ETCOc

Other: Carboxyhemoglobin
Laboratory assay of carboxyhemoglobin levels for the detection of hemolysis
Other Name: COHbc

Primary Outcome Measures :
  1. Age-specific gradations of BBC values for each week of GA and in order to characterize degree of disordered BBC. [ Time Frame: postnatal age 0-7 days ]
    This aim addresses the hy-pothesis that there are functional degrees and extents of BBC that can be objectively graded to quantify insuf-ficient BBC. These data will define BBC ranges to guide objective, accurate thresholds that identify what levelsof TB compared to the BBC is "safe". Infants with insufficient (>45% saturation) and near-normal (<25% satura-tion) BBC will be identified as select cohorts and then further tested for BIND at term-equivalent age.

Secondary Outcome Measures :
  1. Determinants of bilirubin load (using rates of bilirubin production) on BBC [ Time Frame: postnatal age 0-7 days ]
    This aim addresses the hypothesis that biochemical markers of bilirubin load, individually or collectively, relat-ed to excessive bilirubin production and insufficient BBC, define the mechanisms of bilirubin load for matura-tional age (both term PMA and GA). The studies are directed toward translating diverse components of biliru-bin loads: serum albumin, BBC, and TB rate-of-rise and decrease. These data will integrate measurements of bilirubin load using established indices of bilirubin production that accurately characterize early signs of BIND at term equivalent age that may be associated with neuroanatomical changes, and NDI.

Other Outcome Measures:
  1. Infants most at-risk for BIND prior to discharge (up to 55 weeks) for subtle or direct evidence of NDI at term equivalent age. [ Time Frame: >=55 weeks PMA ]
    This aim addresses the hypothesis that acute phenotypic measures of BIND at TEA are identified most in preterm infants who have insufficient BBC. These data will detect perturbations in any or all domains of visuo-oculomotor, auditory, neuroanatomical (MRI) and neurodevel-opmental functions.

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Ages Eligible for Study:   24 Weeks to 34 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Inpatient premature infants

Inclusion Criteria:

  • Patients (GA 24 to ≤34 wks)

Exclusion Criteria:

  • Major life-threatening anomalies and diagnosed inborn errors of metabolic disorders
  • Attending physician or parent refusal

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 identifier (NCT number): NCT02691156

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Contact: Vinod K Bhutani, MD 1-(650) 723-5711
Contact: Martin E Castillo, BS 1-(650) 723-5711

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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   
Contact: Martin E Castillo Cuadrado, BS    (650) 723-5711   
Principal Investigator: Vinod K Bhutani, MD         
Sponsors and Collaborators
Stanford University
Smith-Kettlewell Eye Research Institute
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Principal Investigator: Vinod K Bhutani, MD Stanford University

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Responsible Party: Vinod K. Bhutani, MD, FAAP, Stanford University Identifier: NCT02691156    
Other Study ID Numbers: IRB-31187
First Posted: February 25, 2016    Key Record Dates
Last Update Posted: October 9, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Vinod K. Bhutani, Stanford University:
Additional relevant MeSH terms:
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Neurologic Manifestations
Birth Weight
Body Weight
Pathologic Processes
Nervous System Diseases
Brain Diseases, Metabolic
Brain Diseases
Central Nervous System Diseases
Erythroblastosis, Fetal
Hematologic Diseases
Infant, Newborn, Diseases
Metabolic Diseases
Immune System Diseases
Carbon Monoxide
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Protective Agents