Evaluation of a Smartphone Based Optical Diagnostic Tool for Neonatal Jaundice

April 9, 2020 updated by: St. Olavs Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

342

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway
        • Akershus University Hospital
      • Trondheim, Norway
        • St Olavs Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 2 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: newborn infants checked for jaundice
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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between bilirubin estimates by smartphone pictures and by blood samples
Time Frame: 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.
5 minutes
Correlation between bilirubin estimates by smartphone pictures and by transcutaneous measurements
Time Frame: 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.
5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Olavs Hospital

Collaborators

Norwegian University of Science and Technology
University Hospital, Akershus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

March 15, 2019

Study Completion (Actual)

March 15, 2019

Study Registration Dates

First Submitted

December 20, 2016

First Submitted That Met QC Criteria

December 28, 2016

First Posted (Estimate)

January 2, 2017

Study Record Updates

Last Update Posted (Actual)

April 13, 2020

Last Update Submitted That Met QC Criteria

April 9, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014/619

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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