MedTrace Logo

Evaluation of a Smartphone Based Optical Diagnostic Tool for Neonatal Jaundice

NCT03007563 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 342

Last updated 2020-04-13

No results posted yet for this study

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.

Conditions

  • Jaundice, Neonatal
  • Hyperbilirubinemia, Neonatal

Interventions

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

Sponsors & Collaborators

  • Norwegian University of Science and Technology

    collaborator OTHER

  • University Hospital, Akershus

    collaborator OTHER

  • St. Olavs Hospital

    lead OTHER

Principal Investigators

  • Siri Forsmo, md prof · Norwegian University of Science and Technology

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Day
Max Age
14 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2019-03-15
Completion
2019-03-15

Countries

  • Norway

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03007563 on ClinicalTrials.gov