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Clinical Trials/NCT03007563
NCT03007563
Completed
Not Applicable

Evaluation of a Smartphone Based Optical Diagnostic Tool for Neonatal Jaundice

St. Olavs Hospital2 sites in 1 country342 target enrollmentJanuary 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Jaundice, Neonatal
Sponsor
St. Olavs Hospital
Enrollment
342
Locations
2
Primary Endpoint
Correlation between bilirubin estimates by smartphone pictures and by blood samples
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2017
End Date
March 15, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
St. Olavs Hospital
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

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.

Study Sites (2)

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