Trials / Completed
CompletedNCT05650463
Evaluation of a Smartphone-based Screening Tool (Picterus Jaundice Pro) for Neonatal Jaundice in Dark Skin Newborns
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 150 (actual)
- Sponsor
- Picterus AS · Industry
- Sex
- All
- Age
- 1 Day – 14 Days
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2021-11-29
- Primary completion
- 2021-11-29
- Completion
- 2022-08-31
- First posted
- 2022-12-14
- Last updated
- 2023-03-29
Locations
1 site across 1 country: Sweden
Source: ClinicalTrials.gov record NCT05650463. Inclusion in this directory is not an endorsement.