An interventional study of Picterus Jaundice Pro in Jaundice, Neonatal, sponsored by Picterus AS. Completed at 1 site in Mexico. Open to participants aged 0 Days to 14 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-21.
Sponsored by Picterus AS · Not applicable, Interventional, and Screening
This corss-sectional study aims to test the performance and accuracy of the Picterus JP screening device in newborns with different skin types.
A descriptive cross-sectional study among 174 newborns was carried out at Hospital Materno-Infantil de Irapuato in Mexico during July and August 2018.
The Picterus Calibration Card will be placed on the chest of the newborn with the hole in the card placed over the infant's sternum. A validated smartphone with Picterus JP will be used to collect digital images..
105 studies on the registry are indexed under Jaundice, Neonatal; 27 are open to participants now.
This study's enrollment of 174 is above the median of 134 across 74 interventional 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.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
There is only one arm in this study which is to enable high qualitative estimation of bilirubin levels in the blood of new-borns, independent of skin color, using Picterus JP.
Device: Picterus Jaundice Pro
Use Picterus Jaundice Pro, a smartphone app that is used to take photo of the newborns skin, where the Picterus calibration card is place.
Also known as: Picterus JP
Enable high qualitative estimation of bilirubin levels in the blood of newborns using Picterus JP
Evaluate of smartphone-based diagnostic tool (Picterus JP) for neonatal jaundice in newborns.
Time frame: 6 months
Correlation with TsB
Demonstrate the correlation among the estimated levels of bilirubin obtained through a smartphone based diagnostic tool with bilirubin serum levels in a population of Mexican neonates.
Time frame: 1-2 hours
Correlation with TcB
Demonstrate the correlation among the estimated levels of bilirubin obtained through a smartphone based diagnostic tool with those obtained using a transcutaneous bilirubinometer in a population of Mexican neonates.
Time frame: 5-10 minutes
Correlation with visual assessment
Demonstrate the correlation among the estimated levels of bilirubin obtained through a smartphone based diagnostic tool with those obtained using visual Kramer scale in a population of Mexican neonates.
Time frame: 5-10 minutes
Plan to share: No
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Picterus AS