Evaluation of a Smartphone Based Optical Diagnostic Tool for Neonatal Jaundice
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|ClinicalTrials.gov Identifier: NCT03007563|
Recruitment Status : Recruiting
First Posted : January 2, 2017
Last Update Posted : November 14, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Jaundice, Neonatal Hyperbilirubinemia, Neonatal||Device: bilirubin concentration estimation from smartphone pictures Procedure: bilirubin concentration measured in standard blood samples Device: bilirubin concentration measured by transcutaneous device||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of a Smartphone Based Optical Diagnostic Tool for Neonatal Jaundice|
|Actual Study Start Date :||January 2017|
|Estimated Primary Completion Date :||April 1, 2019|
|Estimated Study Completion Date :||April 1, 2019|
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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03007563
|Contact: Anders Aune||0047 firstname.lastname@example.org|
|Akershus University Hospital||Recruiting|
|Contact: Britt Nakstad, MD|
|Contact: Anne Lee Solevåg|
|Sub-Investigator: Hanne Bui|
|St Olavs Hospital||Completed|
|Study Director:||Siri Forsmo, md prof||Norwegian University of Science and Technology|