Evaluation of a Smartphone Based Optical Diagnostic Tool for Neonatal Jaundice

St. Olavs Hospital

Status: Completed

Conditions: Hyperbilirubinemia, Neonatal; Jaundice, Neonatal

Treatments: Device: bilirubin concentration measured by transcutaneous device; Device: bilirubin concentration estimation from smartphone pictures; Procedure: bilirubin concentration measured in standard blood samples

Study type: Interventional

Funder types: Other

Identifiers

NCT03007563

2014/619

Details and patient eligibility

About

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.

Enrollment: 342 patients

Sex: All

Ages: 1 to 14 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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342 participants in 1 patient group

newborn infants checked for jaundice

Experimental group

Description:

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.

Treatment:

Device: bilirubin concentration estimation from smartphone pictures

Device: bilirubin concentration measured by transcutaneous device

Procedure: bilirubin concentration measured in standard blood samples