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| ID | Type | Description | Link |
|---|---|---|---|
| R44HD090778 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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The goal of this study is to assess the accuracy of BiliCam, a non-invasive technology based on analysis of digital images obtained with an app installed on a commercial smartphone, in estimating total serum bilirubin levels in newborns. BiliCam estimated bilirubin levels will be compared to total serum bilirubin levels in up to 225 newborns.
Jaundice, a yellowing of the skin and eyes caused by a build up of bilirubin in the blood, is a common problem in newborn infants. Measurement of total serum bilirubin (TSB) levels is used for clinical decision making. BiliCam is a non-invasive technology used to estimate TSB levels in newborns. With BiliCam, the user obtains digital images of a small portion of a newborn's skin using the BiliCam app installed on a commercial smartphone in a standardized manner. A color calibration card is placed on the baby's sternum to account for varying light conditions. Data on color levels in the photos are used to estimate a bilirubin level.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Newborns | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BiliCam estimated bilirubin (BCB) | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| BCB - TSB Correlation | Pearson correlation coefficient between paired BCB- TSB measurements | Newborns up to 192 hours old |
| Measure | Description | Time Frame |
|---|---|---|
| Intercept of Regression Line | The intercept of the regression line of paired BCB TSB values is reported (BCB is the y-axis and TSB is the x-axis). | Newborns up to 192 hours old |
| Slope of Regression Line |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Jefferson University Hopsital | Philadelphia | Pennsylvania | 19017 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Age was only measured on the 150 participants who completed a study visit
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | A total of 203 participants were consented. Age was not obtained until the study visit; 150 participants had a study visit |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | BCB - TSB Correlation | Pearson correlation coefficient between paired BCB- TSB measurements | Participants who completed study visit and had valid paired TSB-BCB results. There were 3 participants in whom blood was obtained for TSB levels, but no valid measurement was available (1 grossly hemolyzed sample, 1 specimen lost, and 1 specimen not obtained within 2 hours of the BCB level). There were 3 participants in whom a BCB level could not be obtained by the study device. | Posted | Number | correlation coefficient | Newborns up to 192 hours old |
|
Adverse events related to the study device through study completion, for an average of 30 minutes
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James Taylor | BiliCam, LLC | 2064194923 | uncjat@google.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 1, 2017 | Mar 17, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007567 | Jaundice, Neonatal |
| ID | Term |
|---|---|
| D051556 | Hyperbilirubinemia, Neonatal |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006932 | Hyperbilirubinemia |
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The slope of the regression line of paired BCB TSB values is reported (BCB is the y-axis and TSB is the x-axis).
| Newborns up to 192 hours old |
| Received phtototherapy prior to study visit=4, blood specimen not obtained =1 |
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| Mean |
| Standard Deviation |
| hours |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Intercept of Regression Line | The intercept of the regression line of paired BCB TSB values is reported (BCB is the y-axis and TSB is the x-axis). | Participants with valid paired BCB and TSB values | Posted | Number | 95% Confidence Interval | mg/dL | Newborns up to 192 hours old |
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| Secondary | Slope of Regression Line | The slope of the regression line of paired BCB TSB values is reported (BCB is the y-axis and TSB is the x-axis). | Participants with valid paired BCB and TSB values | Posted | Number | 95% Confidence Interval | slope | Newborns up to 192 hours old |
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| 0 |
| 151 |
| 0 |
| 151 |
| 0 |
| 151 |
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| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |