Identification of Jaundice in Newborns Using Smartphones

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.

Study Overview

• Status: Completed
• Conditions: Hyperbilirubinemia, Neonatal; Jaundice, Neonatal
• Intervention / Treatment: Device: Bilirubin estimates from Smartphone Application; Diagnostic test: Bilirubin concentration measured in standard blood samples; Device: Bilirubin estimates from standard transcutaneous device; Other: Visual assessment of jaundice

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.

• Study Type: Interventional
• Enrollment (Actual): 220
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Haugesund, Norway
    • Haugesund Hospital
  • Trondheim, Norway
    • St Olavs Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Born in St.Olavs hospital, Trondheim or in Haugesund Hospital, Norway
• Born with gestational age >36+6
• Birth weight ≥ 2500g and <4500g
• Age 1 - <15 days
• Are having a blood sample performed, as newborn screening or for jaundice assessment

Exclusion criteria:

Infants needing intensive treatment. This includes:

• Infants in the need for respiratory support
• Infants with conditions that could compromise skin circulation, as sepsis, heart failure or other
• Infants that have received phototherapy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Newborns in St.Olavs Hospital and Haugesund Hospital; All newborns will be examined through 4 different methods of determining jaundice.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Smartphone application sensitivity	Sensitivity of the smartphone application to detect severe jaundice, defined as total serum bilirubin value > 250 umol/l.	5 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Repeatability	To evaluate the repeatability of multiple measurements with the new smartphone tool	5 min
Correlation between bilirubin estimates by smartphone pictures and by total serum bilirubin	Estimate of bilirubin levels from smartphone pictures, compared with bilirubin measurements in total serum. Correlation will be expressed by Pearson correlation coefficient, r.	5 minutes
Correlation between bilirubin estimates by smartphone pictures and by standard transcutaneous readings.	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. Correlation will be expressed by Pearson correlation coefficient, r.	5 minutes
Correlation between bilirubin estimates by smartphone pictures and visual assessment 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	5 min

Collaborators and Investigators

• Sponsor: St. Olavs Hospital
• Collaborators: Norwegian University of Science and Technology; Helse Fonna

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2020
• Primary Completion (Actual): September 15, 2020
• Study Completion (Actual): September 15, 2020

Study Registration Dates

• First Submitted: November 27, 2019
• First Submitted That Met QC Criteria: November 27, 2019
• First Posted (Actual): December 2, 2019

Study Record Updates

• Last Update Posted (Actual): September 26, 2022
• Last Update Submitted That Met QC Criteria: September 22, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Infant, Newborn; Diagnosis; Cell Phones; Skin Pigmentation
• Additional Relevant MeSH Terms: Pathologic Processes; Infant, Newborn, Diseases; Skin Manifestations; Jaundice; Hyperbilirubinemia; Hyperbilirubinemia, Neonatal; Jaundice, Neonatal; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Antioxidants; Bilirubin
• Other Study ID Numbers: 2018/1608

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No