NCT03007563

Evaluation of a Smartphone Based Optical Diagnostic Tool for Neonatal Jaundice

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 342 (actual)
• Sponsor: St. Olavs Hospital · Academic / Other
• Sex: All
• Age: 1 Day – 14 Days
• Healthy volunteers: Not accepted

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.

Conditions

• Jaundice, Neonatal
• Hyperbilirubinemia, Neonatal

Interventions

Type	Name	Description
DEVICE	bilirubin concentration estimation from smartphone pictures	pictures taken of the skin covering the breast bone
PROCEDURE	bilirubin concentration measured in standard blood samples
DEVICE	bilirubin concentration measured by transcutaneous device

Timeline

• Start date: 2017-01-01
• Primary completion: 2019-03-15
• Completion: 2019-03-15
• First posted: 2017-01-02
• Last updated: 2020-04-13

Locations

2 sites across 1 country: Norway