Clinical TrialID 1691

Bilirubin Binding Capacity to Assess Bilirubin Load in Preterm Infants

NCT02691156

Bilirubin-induced Neurologic Dysfunction|Hyperbilirubinemia|Kernicterus|Infant, Premature|Infant, Low Birth Weight

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Record Fields

Scalar fields from the final clinical_trial record.

Clinical Trial Id
1691
Evidence Id
1691
Core Evidence Id
1691
Source Clinical Trial Id
1663
Herb2 Clinical Trial Id
HBCT001663
Nct Id
NCT02691156
Title
Bilirubin Binding Capacity to Assess Bilirubin Load in Preterm Infants
Status
Completed
Phase
Study Result
No
Study Condition
Bilirubin-induced Neurologic Dysfunction|Hyperbilirubinemia|Kernicterus|Infant, Premature|Infant, Low Birth Weight
Study Type
Observational
Study Design
Observational Model: |Time Perspective: p
Intervention
DIAGNOSTIC_TEST: Bilirubin Binding Capacity|DIAGNOSTIC_TEST: End-tidal Carbon Monoxide|DIAGNOSTIC_TEST: Carboxyhemoglobin
Intervention Allocation
Intervention Model
Intervention Mask
Intervention Purpose
Gender
All
Age
Child
Enrollment
143
Outcome Measure
Age-specific gradations of BBC values for each week of GA and in order to characterize degree of disordered BBC., 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., postnatal age 0-7 days
Sponsor Collaborator
Stanford University|Smith-Kettlewell Eye Research Institute
Funded By
OTHER
Location
Lucile-Packard Children's Hospital at Stanford, Stanford, California, 94305, United States
Other Id
IRB-31187
Start Date
2016-02-01
Primary Completion Date
2018-08-31
Completion Date
2018-08-31
First Posted
2016-02-25
Results First Posted
Last Update Posted
2021-10-01
Study Document
Study Url
https://clinicaltrials.gov/study/NCT02691156
Title Cn
Title En
Bilirubin Binding Capacity to Assess Bilirubin Load in Preterm Infants
Bilingual Status
semi_complete