Evaluation of a Smartphone Based Screening Tool for Neonatal Jaundice in Surabaya, Indonesia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Jaundice, Neonatal
- Sponsor
- Picterus AS
- Enrollment
- 284
- Locations
- 3
- Primary Endpoint
- Enable high qualitative estimation of bilirubin levels in the blood of newborns, independent of skin color, using Picterus JP.
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Enable high qualitative estimation of bilirubin levels in the blood of newborns, independent of skin color, using Picterus JP.
Time Frame: 5-10 minutes
Evaluate of smartphone-based screening tool (Picterus JP) for neonatal jaundice in Indonesian newborns.
Secondary Outcomes
- correlation between bilirubin estimates from a smartphone application and bilirubin estimates from a standard transcutaneous device in newborns(5-10 minutes)
- Correlation between bilirubin estimates in from a smartphone application and bilirubin measurements in serum in newborn(1-2 minutes)
- Correlation between bilirubin estimates from a smartphone application and bilirubin estimates from visual inspection in newborns(5-10 minutes)