Neonatal Jaundice
Conditions
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
Interventions
DEVICEsmartphone-based screening tool for neonatal jaundice
In this study we aim to collect data of newborns with wider range of bilirubin levels and high melanin content, 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 for all skin colors. .
Sponsors
Norwegian University of Science and Technology
Picterus AS
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
24 Hours to 14 Days
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Smartphone application sensitivity (bilirubin levels on newborns) | 5 minutes | Enable high qualitative estimation of bilirubin levels in the blood of newborns, independent of skin color, using Picterus JP. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Smartphone application sensitivity (bilirubin levels on newborns with high melanin content) in the skin. | 5 minutes | Enable high qualitative estimation of bilirubin levels in the blood of newborns, independent of skin color, using Picterus JP. Adapt the current algorithm of Picterus JP to newborns with high melanin content in the skin |
Countries
Uganda
Outcome results
None listed