Jaundice, Neonatal
Conditions
Brief summary
A cross-sectional conductive study aiming to evaluate the accuracy of a novel smartphone application that estimates bilirubin levels in newborns in Surabaya.
Detailed description
A cross-sectional conductive study aiming to evaluate the accuracy of a novel smartphone application that estimates bilirubin levels in newborns at Airlangga University hospital and RSIA Kendangsari MERR in Surabaya. This cross-sectional study evaluates the accuracy of a novel smartphone application that estimates bilirubin levels in Indonesian newborns. The Picterus Calibration Card was 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 was used to collect digital images.
Interventions
DEVICEPicterus Jaundice Pro
In this study we aim to collect data of newborns with wider range of bilirubin levels 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 for all skin colors.
Sponsors
RSIA Kendangsaru Surabaya
Universitas Airlangga
Picterus AS
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Hours to 14 Days
Healthy volunteers
Yes
Inclusion criteria
* Infants born with gestational age \>31 * Birth weight ≥ 1500g * Age 0 - ≤14 days * Consent obtained from the parents
Exclusion criteria
* Infants born with congenital abnormalities; * Infants respiratory support; * Infants suffering from a condition that may alter the skin tissue circulatory system, such as sepsis and heart failure; * Infants who have received phototherapy in the last 24 hours.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Enable high qualitative estimation of bilirubin levels in the blood of newborns, independent of skin color, using Picterus JP. | 5-10 minutes | Evaluate of smartphone-based screening tool (Picterus JP) for neonatal jaundice in Indonesian newborns. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between bilirubin estimates in from a smartphone application and bilirubin measurements in serum in newborn | 1-2 minutes | To evaluate the correlation between bilirubin estimates in from a smartphone application and bilirubin measurements in serum in newborns with varying degree of jaundice |
| correlation between bilirubin estimates from a smartphone application and bilirubin estimates from a standard transcutaneous device in newborns | 5-10 minutes | To evaluate the correlation between bilirubin estimates from a smartphone application and bilirubin estimates from a standard transcutaneous device in newborns with varying degree of jaundice |
| Correlation between bilirubin estimates from a smartphone application and bilirubin estimates from visual inspection in newborns | 5-10 minutes | To evaluate the correlation between bilirubin estimates from a smartphone application and bilirubin estimates from visual inspection in newborns with varying degree of jaundice |
Countries
Indonesia
Outcome results
None listed