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NCT02691156 · ClinicalTrials.gov registry record
Bilirubin Binding Capacity to Assess Bilirubin Load in Preterm Infants
A clinical trial, sponsored by Stanford University.
- Completed
- Registry status
- 143
- Enrollment target
NCT02691156: Completed study, sponsored by Stanford University.
NCT02691156 is a clinical trial that has completed, run by Stanford University. The registered enrollment target is 143 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02691156 has completed, sponsored by Stanford University.
- COMPLETED
- Registry status
- 143 participants
- Enrollment target
Study 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.
Primary Outcome
This aim addresses the hypothesis that there are functional degrees and extents of BBC that can be objectively graded to quantify insufficient BBC. These data will define BBC ranges to guide objective, accurate thresholds that identify what levels of TB compared to the BBC is "safe". Infants with insufficient (\>45% saturation) and near-normal (\<25% saturation) BBC will be identified as select cohorts and then further tested for BIND at term-equivalent age.
Interventions
- DIAGNOSTIC_TEST Bilirubin Binding Capacity
- DIAGNOSTIC_TEST End-tidal Carbon Monoxide
- DIAGNOSTIC_TEST Carboxyhemoglobin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 143 participants |
| Start Date | 2016-02-01 |
| Est. Completion | 2018-08-31 |
What the finished NCT02691156 record still lists
NCT02691156 is an observational study that tracks outcomes without assigning an intervention. The registered 143 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 3 interventions - of which Bilirubin Binding Capacity is the first listed.
NCT02691156 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02691156 about?
NCT02691156 is a clinical study titled "Bilirubin Binding Capacity to Assess Bilirubin Load in Preterm Infants". 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 ...
What is the current status of trial NCT02691156?
This trial is currently completed. The enrollment target is 143 participants. The study started on 2016-02-01. Estimated completion is 2018-08-31.
What interventions are being tested in trial NCT02691156?
The interventions under investigation include: Bilirubin Binding Capacity (DIAGNOSTIC_TEST), End-tidal Carbon Monoxide (DIAGNOSTIC_TEST), Carboxyhemoglobin (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT02691156?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
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