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Bilirubin Binding Capacity to Assess Bilirubin Load in Preterm Infants
Not Recruiting
Trial ID: NCT02691156
Purpose
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.
Official Title
Bilirubin Binding Capacity to Assess Bilirubin Load in Preterm Infants
Stanford Investigator(s)
Eligibility
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
Intervention(s):
diagnostic test: Bilirubin Binding Capacity
diagnostic test: End-tidal Carbon Monoxide
diagnostic test: Carboxyhemoglobin
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Vinod K Bhutani, MD
650-723-5711