Bilirubin Binding Capacity to Assess Bilirubin Load in Preterm Infants
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|ClinicalTrials.gov Identifier: NCT02691156|
Recruitment Status : Recruiting
First Posted : February 25, 2016
Last Update Posted : October 9, 2017
|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|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|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|
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
Laboratory assay of carboxyhemoglobin levels for the detection of hemolysis
Other Name: COHbc
- 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.
- 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.
- 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.
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): NCT02691156
|Contact: Vinod K Bhutani, MD||1-(650) firstname.lastname@example.org|
|Contact: Martin E Castillo, BS||1-(650) email@example.com|
|United States, California|
|Lucile-Packard Children's Hospital at Stanford||Recruiting|
|Stanford, California, United States, 94305|
|Contact: Vinod K Bhutani, MD 650-723-5711 firstname.lastname@example.org|
|Contact: Martin E Castillo Cuadrado, BS (650) 723-5711 email@example.com|
|Principal Investigator: Vinod K Bhutani, MD|
|Principal Investigator:||Vinod K Bhutani, MD||Stanford University|