Trials / Unknown
UnknownNCT05630495
Validation of an Innovative Neonatal Jaundice Detection System (Picterus) in Indonesia
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- Sponsor
- Picterus AS · Industry
- Sex
- All
- Age
- 1 Day – 14 Days
- Healthy volunteers
- Accepted
Summary
The long-term goal of this project is to establish Picterus as a permanent tool to detect NNJ in the healthcare services of Indonesia. Offering early detection and therefore, timely treatment to NNJ, will substantially improve neonatal health and directly work towards the Sustainable Development Goal 3.2.2, reduce neonatal mortality. The study as the following specific subgoals: * Demonstrate that Picterus system performs accurately in Indonesian newborns * Ensure that Picterus is in line with users' needs in Indonesia
Detailed description
The long-term goal of this project is to establish Picterus as a permanent tool to detect NNJ in the healthcare services of Indonesia. Offering early detection and therefore, timely treatment to NNJ, will substantially improve neonatal health and directly work towards the Sustainable Development Goal 3.2.2, reduce neonatal mortality. The study as the following specific subgoals: * Demonstrate that Picterus system performs accurately in Indonesian newborns * Ensure that Picterus is in line with users' needs in Indonesia
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
- 2022-12-12
- Primary completion
- 2023-12-15
- Completion
- 2024-05-15
- First posted
- 2022-11-29
- Last updated
- 2023-07-14
Locations
2 sites across 1 country: Indonesia
Source: ClinicalTrials.gov record NCT05630495. Inclusion in this directory is not an endorsement.