Neonatal Jaundice
Conditions
Keywords
jaundice, neonate, phototherapy
Brief summary
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.
Detailed description
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.
Interventions
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).
Sponsors
Intermountain Medical Center
Picterus AS
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
12 Hours to 192 Hours
Healthy volunteers
Yes
Inclusion criteria
* the patient is free of skin rash, bruising, or other medical conditions that can interfere with transcutaneous measurement * (preterm) \< = 35 weeks gestational age * (term) \> 35 weeks gestational age * the patient has not been excluded by PI discretion.
Exclusion criteria
* Neonates will be excluded from participation if all four inclusion criteria listed above are not met.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Enable high qualitative estimation of bilirubin levels in the blood of term and preterm newborns undergoing phototherapy using Picterus JP. | 2 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlate the bilirubin measurement from Picterus JP with serum bilirubin levels from term-born babies without phototherapy. | 2 hours | Evaluate the correlation between Picterus JP bilirubin measurements and blood serum measurements in term-born babies without phototherapy. |
| Correlate the bilirubin measurement from Picterus JP with serum bilirubin levels from preterm-born babies without phototherapy. | 2 hours | Evaluate the correlation between Picterus JP bilirubin measurements and blood serum measurements in preterm-born babies without phototherapy. |
| Correlate the bilirubin measurement from Picterus JP with serum bilirubin levels from term-born babies who have received phototherapy. | 2 hours | Evaluate the correlation between Picterus JP bilirubin measurements and blood serum measurements in term-born babies who have received phototherapy. |
| Correlate the bilirubin measurement from Picterus JP with serum bilirubin levels from preterm-born babies who have received phototherapy. | 2 hours | Evaluate the correlation between Picterus JP bilirubin measurements and blood serum measurements in preterm-born babies who have received phototherapy. |
Countries
United States
Contacts
Primary ContactTimothy M Bahr, MS MD
Backup ContactKimberlee W Lewis, MS RN
Outcome results
None listed