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Evaluation of a Smartphone Based Optical Diagnostic Tool for Neonatal Jaundice

Not Applicable
Completed
Conditions
Jaundice, Neonatal
Hyperbilirubinemia, Neonatal
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

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
Primary Outcome Measures
NameTimeMethod
Correlation between bilirubin estimates by smartphone pictures and by blood samples5 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 measurements5 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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (2)

Akershus University Hospital

🇳🇴

Oslo, Norway

St Olavs Hospital

🇳🇴

Trondheim, Norway

Akershus University Hospital
🇳🇴Oslo, Norway

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