Clinical Trial: Bilirubin Binding Capacity to Assess Bilirubin Load in Preterm Infants
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title: Bilirubin Binding Capacity to Assess Bilirubin Load in Preterm Infants
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.
Detailed Summary:
The investigator intends to first collect simultaneous and comprehensive "acute phase" measurements of TB, BBC, ETCOc, and COHbc in MPT infants. The investigator will then seek to understand precisely the relationship between GA, TB, BBC, ETCOc, and COHbc levels and the domains of BIND. Third, The investigator will provide a comprehensive database that can be used to improve current neonatal BIND screening practices in the context of lowered and higher BBC. The investigator's working hypothesis is that exposures to modest TB levels in the presence of significantly diminished BBC in the developing neonate result in residual deficits of one or more neuroprocessing function (BIND) at TEA.
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Patients (GA 24 to <34 wks) will be enrolled. Subject exclusion criteria: Major life-threatening anomalies and diagnosed inborn errors of metabolic disorders; attending physician or parent refusal.
Clinical data collection: After receiving written informed consent, the research team will complete clinical data forms for infant demographics. The data forms will be consistent with and abstracted from the medical record. No additional information will be collected for this exploratory study.
Population: The entire cohort will compromise 60-80 patients. From this cohort, 12 at-risk infants with most impaired BBC and matched with those designated as low-risk will be re-recruited for the follow-up to identify any evidence of BIND in any or all 4 of the outcome variables.
Laboratory data: Once inclusion criteria are met, routine neonatal laboratory tests will be as clinically ordered. Each infant will tested for BBC and ETCOc at least 2 intervals (maximum 4 ov
Sponsor: Stanford University
Current Primary Outcome: 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.
Original Primary Outcome: Same as current
Current Secondary Outcome: 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.
Original Secondary Outcome: Same as current
Information By: Stanford University
Dates:
Date Received: February 16, 2016
Date Started: December 2015
Date Completion:
Last Updated: April 14, 2016
Last Verified: April 2016
