An observational study in Neonatal Jaundice, sponsored by Picterus AS. Recruiting at 1 site in United States. Open to participants aged 12 Hours to 192 Hours, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-26.
Sponsored by Picterus AS · Observational
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.
110 studies on the registry are indexed under Jaundice, Neonatal; 28 are open to participants now.
This study's planned enrollment of 500 is above the median of 405 across 27 observational studies indexed under Jaundice, Neonatal.
Browse Jaundice, Neonatal studies →Picterus AS is the lead sponsor of 11 studies on the registry; 3 are open to participants now.
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newborns
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Exclusion Criteria:
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.
Device: Picterus Jaundice Pro (JP)
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).
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
Time frame: 2 months
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.
Time frame: 2 hours
Correlate the bilirubin measurement from Picterus JP with serum bilirubin levels from preterm-born babies without phototherapy.
Evaluate the correlation between Picterus JP bilirubin measurements and blood serum measurements in preterm-born babies without phototherapy.
Time frame: 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.
Time frame: 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.
Time frame: 2 hours
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