CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 143 enrolled
Drug / intervention
Bilirubin Binding Capacity +2 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02691156
NCT02691156N/ACompleted

Bilirubin Binding Capacity to Assess Bilirubin Load in Preterm Infants

Stanford University·observational·Posted Feb 25, 2016·Updated Oct 1, 2021

In Brief

An observational study evaluating Bilirubin Binding Capacity, End-tidal Carbon Monoxide, and 1 other intervention for Bilirubin-induced Neurologic Dysfunction and 4 related conditions. Completed, enrolled 143 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedFeb 25, 2016
Enrollment StartFeb 1, 2016
Primary CompletionAug 31, 2018
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 10.4 years ago

Interventions

Bilirubin Binding Capacityother

Research laboratory assay of bilirubin binding capacity

End-tidal Carbon Monoxideother

Noninvasive bedside test to measure exhaled end-tidal carbon monoxide levels for the detection of hemolysis

Carboxyhemoglobinother

Laboratory assay of carboxyhemoglobin levels for the detection of hemolysis