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| Name | Class |
|---|---|
| Intermountain Health Care, Inc. | OTHER |
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The goal of this project is to evaluate the performance of Picterus Jaundice Pro in an American population, including preterm and term newborns and pre- and post- phototherapy.
The purpose of this study is to compare serum bilirubin levels with non-invasive bilirubin measurements in neonates during the first 12 to 192 hours of life using the "Picterus Jaundice Pro" smartphone application with a proprietary calibration card placed over the neonate's sternum. We will also validate the accuracy of Picterus Jaundice Pro bilirubin measurements before and after phototherapy treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Term-born babies & preterm born babies | We will collect 300 paired (serum bilirubin and Picterus Jaundice Pro) measurements on eligible neonates >35 weeks' gestation admitted to a well-baby nursery. Of these, 150 paired measurements will be from neonates who have already received phototherapy (either on phototherapy or status/post phototherapy) and had a light-occlusive adhesive skin patch in place. Each subject >35 weeks gestation can have up to 5 measurements during the study. We will collect 200 paired (serum bilirubin and Picterus) measurements on eligible neonates <35 weeks gestation. Of these, 100 paired measurements will be from neonates who have already received phototherapy (either on phototherapy or status/post phototherapy) and had a light-occlusive adhesive skin patch in place. Each subject <35 weeks gestation can have up to 5 measurements during the study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Picterus Jaundice Pro (JP) | Device | Picterus Jaundice Pro photos will be obtained of enrolled subjects each time the patient has a serum bilirubin level obtained. Up to five paired measurements will be obtained per enrolled subject. The study nurse will place the proprietary calibration card over the subject's sternum and take six Picterus Jaundice Pro photos using a study iPhone within one hour of the serum bilirubin draw. This process takes less than one minute. After the study photos are obtained, the study nurse will record the serum and Picterus Jaundice Pro values in the data-recording log. In the event an enrolled infant requires phototherapy, a light occlusive adhesive patch will be placed over the center of the chest before phototherapy initiation. When a serum bilirubin level is obtained, the research nurse will remove the patch for a brief moment to take Picterus Jaundice Pro pictures (within one hour of the serum value draw). |
| Measure | Description | Time Frame |
|---|---|---|
| Enable high qualitative estimation of bilirubin levels in the blood of term and preterm newborns undergoing phototherapy using Picterus JP. | Evaluate Picterus JP to screen for neonatal jaundice in term and preterm newborns undergoing phototherapy and use the results to improve the analysis algorithm for this population | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Correlate the bilirubin measurement from Picterus JP with serum bilirubin levels from term-born babies without phototherapy. | Evaluate the correlation between Picterus JP bilirubin measurements and blood serum measurements in term-born babies without phototherapy. | 2 hours |
| Correlate the bilirubin measurement from Picterus JP with serum bilirubin levels from preterm-born babies without phototherapy. |
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Inclusion Criteria:
Exclusion Criteria:
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newborns
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Timothy M Bahr, MS MD | Contact | 801-602-6523 | Tim.Bahr@imail.org | |
| Kimberlee W Lewis, MS RN | Contact | 801-507-7675 | kimberlee.weaverlewis@imail.org |
| Name | Affiliation | Role |
|---|---|---|
| Timothy M Bahr, MS MD | Intermountain Health Care, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Intermountain Health | Recruiting | Salt Lake City | Utah | 84132 | United States |
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| ID | Term |
|---|---|
| D007567 | Jaundice, Neonatal |
| D007565 | Jaundice |
| ID | Term |
|---|---|
| D051556 | Hyperbilirubinemia, Neonatal |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006932 | Hyperbilirubinemia |
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Evaluate the correlation between Picterus JP bilirubin measurements and blood serum measurements in preterm-born babies without phototherapy. |
| 2 hours |
| Correlate the bilirubin measurement from Picterus JP with serum bilirubin levels from term-born babies who have received phototherapy. | Evaluate the correlation between Picterus JP bilirubin measurements and blood serum measurements in term-born babies who have received phototherapy. | 2 hours |
| Correlate the bilirubin measurement from Picterus JP with serum bilirubin levels from preterm-born babies who have received phototherapy. | Evaluate the correlation between Picterus JP bilirubin measurements and blood serum measurements in preterm-born babies who have received phototherapy. | 2 hours |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |