Evaluation of a Smartphone-based Screening Tool for Neonatal Jaundice in a Ugandan Population
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Neonatal Jaundice
- Sponsor
- Picterus AS
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Smartphone application sensitivity (bilirubin levels on newborns)
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
Brief Summary
The general objective of this study is to evaluate the accuracy of a novel smartphone application that estimates bilirubin levels in newborns at HICH Mbarara.
Detailed Description
The general objective of this study is to evaluate the accuracy of a novel smartphone application that estimates bilirubin levels in newborns at HICH Mbarara. The specific objectives for this study are: To evaluate the correlation between bilirubin estimates from a smartphone application and bilirubin measurements in serum in newborns with varying degree of jaundice 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 To evaluate the correlation between bilirubin estimates from a smartphone application and bilirubin estimates from visual inspection in newborns with varying degree of jaundice
Investigators
Eligibility Criteria
Inclusion Criteria
- •Infants born with gestational age ≥37 weeks
- •Birth weight ≥2000g and ≤4500g
- •Age 1 - 14 days
- •Infants requiring a blood sample (newborn screening / clinically suspected jaundice)
Exclusion Criteria
- •Infants transferred to the paediatric 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
Outcomes
Primary Outcomes
Smartphone application sensitivity (bilirubin levels on newborns)
Time Frame: 5 minutes
Enable high qualitative estimation of bilirubin levels in the blood of newborns, independent of skin color, using Picterus JP.
Secondary Outcomes
- Smartphone application sensitivity (bilirubin levels on newborns with high melanin content) in the skin.(5 minutes)