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The purpose of this study is to test the performance of a new transcutaneous ("measured through skin") bilirubin device (BiliCare™) to measure bilirubin levels. The investigators plan to evaluate the clinical performance of this device as a point of care test. If the investigators can validate the BiliCare™ with bilirubin from your baby's blood they could verify a non-invasive alternative for measuring bilirubin.
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| Measure | Description | Time Frame |
|---|---|---|
| In This Study, the Investigators Plan to Test the Performance of a Novel Transcutaneous Device (BiliCareTM) to Screen for Bilirubin Levels at Postnatal Age of 12 to 48 Hours. | 12 to 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
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Up to 100 total participants will be enrolled by the study. Since the goal of the study is to ASSAY SAMPLE FROM BABIES WITH DIVERSE BILIRUBIN LEVELS, the study participants will be moderate premature and mature infants. In particular, the target population will be moderate premature infants at >35 weeks postmenstrual age (PMA) and of term PMA.
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| ID | Title | Description |
|---|---|---|
| FG000 | Late Preterm and Term Newborns | The study population will consist of term and late preterm newborns (infants >=35 weeks gestational age) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
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| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Late Preterm and Term Newborns | The study population will consist of term and late preterm newborns (infants >=35 weeks gestational age) |
| 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 | Gestational Age (GA) in weeks |
| 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 | In This Study, the Investigators Plan to Test the Performance of a Novel Transcutaneous Device (BiliCareTM) to Screen for Bilirubin Levels at Postnatal Age of 12 to 48 Hours. | Posted | Mean | Standard Deviation | mg/dL | 12 to 48 hours |
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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 | Late Preterm and Term Newborns | The study population will consist of term and late preterm newborns (infants >=35 weeks gestational age) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vinod K. Bhutani, MD | Stanford University School of Medicine | (650) 723-5711 | bhutani@stanford.edu |
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| Mean |
| Standard Deviation |
| Weeks |
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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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| JM103 TcB |
The study population will consist of term and late preterm newborns (infants >=35 weeks gestational age) measured with the JM103 TcB device |
| OG003 | Total Serum Bilirubin (TSB) | The study population will consist of term and late preterm newborns (infants >=35 weeks gestational age) measured routinely for total serum bilirubin by diazo method. |
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| 0 |
| 113 |
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| 113 |
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