Hyperbilirubinemia, Neonatal, Jaundice, Neonatal
Conditions
Keywords
Diagnosis, Cell Phones, Infant, Newborn
Brief summary
Neonatal jaundice is a common and most often harmless condition. However, when unrecognized it can be fatal or cause serious brain injury. Three quarters of these deaths are estimated to occur in the poorest regions of the world. The treatment of jaundice, phototherapy, is in most cases easy, low-cost and harmless. The crucial point in reducing the burden of disease is therefore to identify then children at risk. This results in the need for low-cost, reliable and easy-to-use diagnostic tools that can identify newborns with jaundice. Based on previous research on the bio-optics of jaundiced newborn skin, a prototype of a smartphone application has been developed. This prototype will be evaluated in a clinical trial in two hospitals in Norway. A smartphone will be used to take picture of the skin of the newborn, and by using an algorithm an estimate of the bilirubin concentration is made. The results from these estimates will be compared to the bilirubin levels measured in standard blood samples, as well as the results from ordinary transcutaneous measurement devices.
Interventions
DEVICEbilirubin concentration estimation from smartphone pictures
pictures taken of the skin covering the breast bone
DEVICEbilirubin concentration measured by transcutaneous device
Sponsors
Norwegian University of Science and Technology
University Hospital, Akershus
St. Olavs Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Days to 14 Days
Healthy volunteers
No
Inclusion criteria
* born in St.Olavs hospital, Trondheim or in Akershus hospital, Oslo, Norway * born at term * normal birth weight
Exclusion criteria
* in need of advanced medical treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between bilirubin estimates by smartphone pictures and by blood samples | 5 minutes | Estimate of bilirubin levels from smartphone pictures, compared with bilirubin measurement in blood samples in a correlation study. Correlation will be expressed by Pearson correlation coefficient, r. |
| Correlation between bilirubin estimates by smartphone pictures and by transcutaneous measurements | 5 minutes | Estimate of bilirubin levels from smartphone pictures, compared with bilirubin measurements from transcutaneous devices in a correlation study. Correlation will be expressed by Pearson correlation coefficient, r. |
Countries
Norway
Outcome results
None listed