Evaluation of a Smartphone Based Optical Diagnostic Tool for Neonatal Jaundice

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of a Smartphone Based Optical Diagnostic Tool for Neonatal Jaundice

Conditions
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Jaundice, Neonatal, Hyperbilirubinemia, Neonatal

Intervention / Treatment
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* Device: bilirubin concentration estimation from smartphone pictures
* Procedure: bilirubin concentration measured in standard blood samples
* Device: bilirubin concentration measured by transcutaneous device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 14 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: newborn infants checked for jaundice<br>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<br>* pictures taken of the skin covering the breast bone<br>Procedure: bilirubin concentration measured in standard blood samples<br> <br> Device: bilirubin concentration measured by transcutaneous device<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between bilirubin estimates by smartphone pictures and by blood samples | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diagnosis, Cell Phones, Infant, Newborn