Identification of Jaundice in Newborns Using Smartphones
Condition: Jaundice, Neonatal; Hyperbilirubinemia, Neonatal
MeSH terms: Hyperbilirubinemia, Neonatal; Jaundice, Neonatal; Jaundice; Hyperbilirubinemia
Study type: Interventional

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 was developed and tested in a pilot study and the application refined.

      This smartphone application will now be evaluated in a clinical trial set in two hospitals in
      Norway. The smartphone application gives immediate estimates of bilirubin values in newborns,
      and these estimates will be compared to the bilirubin levels measured in standard blood
      samples, as well as the results from ordinary transcutaneous measurement devices.
    

Detailed description: 
      The smartphone jaundice app system works by taking pictures of newborns with a custom-made
      color calibration card placed on their chest. This makes it possible to measure the skin
      color precisely regardless of the specific light source that is used to illuminate the
      newborn. The measured skin color is then compared with items in a database of simulated
      newborn skin colors. These simulated newborn skin colors have been created using numerical
      simulations of how light moves through skin, with varying skin parameters including, but not
      limited to, skin thickness, blood concentration, melanin, and of course bilirubin, the
      pigment that causes jaundice. By comparing the measured skin color with the simulated skin
      colors that are most similar to it, the investigators can then estimate the bilirubin
      concentration in the newborn's skin by e.g. averaging the bilirubin concentrations used to
      create these simulated skin colors.

      In a group of 200 newborns with varying degree of jaundice, correlation between smartphone
      bilirubin estimates will be compared with total serum bilirubin and standard transcutaneous
      bilirubinometry.
    

Intervention name(s): Bilirubin estimates from Smartphone Application; Bilirubin concentration measured in standard blood samples; Bilirubin estimates from standard transcutaneous device; Visual assessment of jaundice
Intervention type(s): Device; Diagnostic Test; Device; Other
Intervention description(s): Bilirubin estimates through color analysis of digital images obtained through smartphone application.; Bilirubin measured in total serum bilirubin.; Bilirubin estimates performed by transcutaneous device ( Dräger JM-105); Degree of jaundice will be assessed by Kramer scale
Intervention MeSH terms: Bilirubin
Intervention model: Single Group Assignment
Intervention model description: 200 newborns with varying degree of jaundice will be recruited.
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Diagnosis; Cell Phones; Infant, Newborn; Skin Pigmentation