Study Results
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View full resultsBasic Information
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COMPLETED
203 participants
INTERVENTIONAL
2017-08-21
2018-04-30
Brief Summary
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Detailed Description
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For the study, paired BiliCam estimated bilirubin (BCB) and TSB levels will be compared on a racially and ethnically diverse sample of newborns. Recruitment will continue until 225 newborns have completed the study.
Conditions
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Study Design
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NA
SINGLE_GROUP
SCREENING
NONE
Study Groups
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Newborns
Newborns will be enrolled in the study in 2 different ways. At "Staged Enrollment" sites, newborns will be enrolled when they are \< 48 hours old. These newborns will have a study visit when they are 48 - 167 hours old. At the study visit, a BCB will be determined and blood will be drawn for study purposes for a TSB level. At "Simultaneous Enrollment" sites, newborns will be enrolled and have a study visit at the time of a blood draw (+/- 2 hours) for a TSB level that is being obtained for clinical purposes. Newborns will be 0-191 hours old.
BiliCam estimated bilirubin (BCB)
Images will be obtained using the BiliCam app installed on a commercial smartphone and used to calculated a BCB level. The BCB levels will be used for study purposes only and not used for clinical care
Interventions
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BiliCam estimated bilirubin (BCB)
Images will be obtained using the BiliCam app installed on a commercial smartphone and used to calculated a BCB level. The BCB levels will be used for study purposes only and not used for clinical care
Eligibility Criteria
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Inclusion Criteria
* Parent speaks and reads English
* Parent provides written informed consent
Exclusion Criteria
* Medical or other complications that preclude completion of the study
0 Hours
191 Hours
ALL
Yes
Sponsors
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National Institutes of Health (NIH)
NIH
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
BiliCam, LLC
INDUSTRY
Responsible Party
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Locations
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Thomas Jefferson University Hopsital
Philadelphia, Pennsylvania, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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52488
Identifier Type: -
Identifier Source: org_study_id
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