Evaluation of a Smartphone Based Optical Diagnostic Tool for Neonatal Jaundice

Not Applicable

Completed

• Conditions: Jaundice, Neonatal; Hyperbilirubinemia, Neonatal
• Interventions: Device: bilirubin concentration estimation from smartphone pictures; Procedure: bilirubin concentration measured in standard blood samples; Device: bilirubin concentration measured by transcutaneous device

• Registration Number: NCT03007563
• Lead Sponsor: St. Olavs Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-12-20
• Study First Submitted QC: 2016-12-28
• Study Start: 2017-01
• Study First Posted: 2017-01-02
• Primary Completion: 2019-03-15
• Study Completion: 2019-03-15
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-09
• Last Update Posted: 2020-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 342

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
newborn infants checked for jaundice	bilirubin concentration measured in standard blood samples	an experimental way of bilirubin concentration estimation from smartphone pictures is applied and compared with two standard methods: bilirubin concentration measured in standard blood samples, and bilirubin concentration measured by transcutaneous device.
newborn infants checked for jaundice	bilirubin concentration estimation from smartphone pictures	an experimental way of bilirubin concentration estimation from smartphone pictures is applied and compared with two standard methods: bilirubin concentration measured in standard blood samples, and bilirubin concentration measured by transcutaneous device.
newborn infants checked for jaundice	bilirubin concentration measured by transcutaneous device	an experimental way of bilirubin concentration estimation from smartphone pictures is applied and compared with two standard methods: bilirubin concentration measured in standard blood samples, and bilirubin concentration measured by transcutaneous device.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Akershus University Hospital; 🇳🇴 Oslo, Norway

St Olavs Hospital; 🇳🇴 Trondheim, Norway