Identification of Jaundice in Newborns Using Smartphones

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.

Conditions

• Jaundice, Neonatal
• Hyperbilirubinemia, Neonatal

Interventions

DEVICE

Bilirubin estimates from Smartphone Application

Bilirubin estimates through color analysis of digital images obtained through smartphone application.

DIAGNOSTIC_TEST

Bilirubin concentration measured in standard blood samples

Bilirubin measured in total serum bilirubin.

DEVICE

Bilirubin estimates from standard transcutaneous device

Bilirubin estimates performed by transcutaneous device ( Dräger JM-105)

OTHER

Visual assessment of jaundice

Degree of jaundice will be assessed by Kramer scale

Sponsors & Collaborators

• Norwegian University of Science and Technology

  collaborator OTHER

• Helse Fonna

  collaborator OTHER

• St. Olavs Hospital

  lead OTHER

Principal Investigators

• Siri Forsmo, md prof · Norwegian University of Science and Technology

Study Design

Allocation

NA

Purpose

SCREENING

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

1 Day

Max Age

14 Days

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-08-03

Primary Completion

2020-09-15

Completion

2020-09-15

Countries

• Norway

Study Locations