Jaundice, Neonatal
Conditions
Brief summary
A cross-sectional study at the Södersjukehuset facility (Stockholm, Sweden) collect data of newborns from a population with Neomar scale type 4 to adjust the algorithm of Picterus JP
Detailed description
To adjust Picterus JP to work in newborns with more pigmented skin, the investigators will collect a data set at Sachsska barnsjukhuset Södersjukhuset, Stockholm Sweden from 150 newborns with dark skins using Picterus JP, TcB, skin measurements from a spectrometer, visual assessment, and total serum bilirubin (TSB) levels. As a control, newborns with Neomar scale 1-3 will be included.
Interventions
DEVICEPicterus 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.
Sponsors
Stockholm South General Hospital
Picterus AS
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Days to 14 Days
Healthy volunteers
Yes
Inclusion criteria
* Infants born with gestational age ≥ 37 * Birth weight ≥ 2500g * Age 1 - 14 days * Will have a blood sample performed, either for clinically suspected jaundice or newborn screening sample
Exclusion criteria
* Infants showing signs of inborn disease * Infants transferred to pediatric ward for treatment * Infants that have received phototherapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Enable high qualitative estimation of bilirubin levels in newborns, independent of skin color, using Picterus JP | 6 months | Evaluate of smartphone-based screening tool (Picterus JP) for neonatal jaundice in newborns with Neomar neonatal skin color scale type 4 (with type 1 being lower-melanin level and Type 4 being higher-melanin level) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Picterus-generated estimate with TsB | 1-2 hours | Compare bilirubin estimates calculated with the adjusted algoritm from the images with TSB measurements |
| Comparison of Picterus-generated estimate with TcB | 5-10min | Compare bilirubin estimates calculated with the adjusted algoritm from the images with TcB measurements |
| Comparison of Picterus-generated estimate with visual assessment. | 5-10min | Compare bilirubin estimates calculated with the adjusted algoritm from the images with visual assessment. |
Countries
Sweden
Outcome results
None listed