Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Universitas Airlangga | OTHER |
| RSIA Kendangsaru MERR Surabaya | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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:
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enable high qualitative estimation of bilirubin levels in the blood of new-borns | Experimental | In this study we aim to collect data of newborns with wider range of bilirubin levels and additionally measurements of skin color reflectance with a spectrophotometer, to adjust the Picterus JP algorithm and optimize the app performance. This will enable a high qualitative estimation of bilirubin levels in the blood of new-borns of South-East Asian ethnicity and skin type. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Picterus Jaundice Pro | Device | Use Picterus Jaundice Pro, a smartphone app that is used to take photo of the newborns skin, where the Picterus calibration card is place. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Enable high qualitative estimation of bilirubin levels in the blood of Indonesian newborns | Enable high qualitative estimation of bilirubin levels in the blood of Indonesian newborns using Picterus JP. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation with TcB | Correlate the estimates of bilirubin levels obtained by Picterus with TcB | 5-10 minutes |
| Correlation with Tsb and TcB | Correlate the estimates of bilirubin levels obtained by Picterus with TSB and TcB |
Not provided
Inclusion Criteria:
- Infants born with gestational age ≥37 weeks Birth weight ≥2000g and ≤4500g Age 1 - 14 days
Exclusion Criteria:
- Infants transferred to the pediatric ward for advanced treatment. Infants with a skin rash or other disease that affects the skin where measurements are performed.
Infants that receive or have received phototherapy in the last 24 hours. Infants with an inborn disease
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mahendra TA Sampurna, Dr, SP.A | Contact | +62 031-5916290 | mahendra.tri@fk.unair.ac.id |
| Name | Affiliation | Role |
|---|---|---|
| Anders Aune, MD,MPH | Picterus AS | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitas Airlangga Teaching Hospital | Recruiting | Surabaya | 60115 | Indonesia |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007567 | Jaundice, Neonatal |
| ID | Term |
|---|---|
| D051556 | Hyperbilirubinemia, Neonatal |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006932 | Hyperbilirubinemia |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 1-2 hours |
| Picterus JP accuracy in Indonesian newborn | Determine the accuracy of Picterus in Indonesian newborns | 6 months |
| RSIA Kendangsari MERR hospital | Completed | Surabaya | 60134 | Indonesia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |