Evaluation of a Smartphone Based Optical Diagnostic Tool for Neonatal Jaundice

Jaundice, Neonatal Clinical Trial

Official title:

Evaluation of a Smartphone Based Optical Diagnostic Tool for Neonatal Jaundice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03007563
• Other study ID #: 2014/619
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: March 15, 2019

Study information

• Verified date: April 2020
• Source: St. Olavs Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 342
• Est. completion date: March 15, 2019
• Est. primary completion date: March 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 14 Days

Eligibility

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

Related Conditions & MeSH terms

• Hyperbilirubinemia
• Hyperbilirubinemia, Neonatal
• Jaundice
• Jaundice, Neonatal

Intervention

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

Locations

Country	Name	City	State
Norway	Akershus University Hospital	Oslo
Norway	St Olavs Hospital	Trondheim

Sponsors (3)

Lead Sponsor	Collaborator
St. Olavs Hospital	Norwegian University of Science and Technology, University Hospital, Akershus

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Aune A, Vartdal G, Bergseng H, Lyngsnes Randeberg L, Darj E. Bilirubin estimates from smartphone images of newborn infants' skin correlated highly to serum bilirubin levels. Acta Paediatr. 2020 Apr 8. doi: 10.1111/apa.15287. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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