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Evaluation of a Smartphone Based Optical Diagnostic Tool for Neonatal Jaundice

Primary Purpose

Jaundice, Neonatal, Hyperbilirubinemia, Neonatal

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
bilirubin concentration estimation from smartphone pictures
bilirubin concentration measured in standard blood samples
bilirubin concentration measured by transcutaneous device
Sponsored by
St. Olavs Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Jaundice, Neonatal focused on measuring Diagnosis, Cell Phones, Infant, Newborn

Eligibility Criteria

1 Day - 14 Days (Child)All SexesDoes not accept 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

Sites / Locations

  • Akershus University Hospital
  • St Olavs Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

newborn infants checked for jaundice

Arm 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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
December 20, 2016
Last Updated
April 9, 2020
Sponsor
St. Olavs Hospital
Collaborators
Norwegian University of Science and Technology, University Hospital, Akershus
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1. Study Identification

Unique Protocol Identification Number
NCT03007563
Brief Title
Evaluation of a Smartphone Based Optical Diagnostic Tool for Neonatal Jaundice
Official Title
Evaluation of a Smartphone Based Optical Diagnostic Tool for Neonatal Jaundice
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
March 15, 2019 (Actual)
Study Completion Date
March 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Olavs Hospital
Collaborators
Norwegian University of Science and Technology, University Hospital, Akershus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Jaundice, Neonatal, Hyperbilirubinemia, Neonatal
Keywords
Diagnosis, Cell Phones, Infant, Newborn

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
342 (Actual)

8. Arms, Groups, and Interventions

Arm Title
newborn infants checked for jaundice
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
bilirubin concentration estimation from smartphone pictures
Intervention Description
pictures taken of the skin covering the breast bone
Intervention Type
Procedure
Intervention Name(s)
bilirubin concentration measured in standard blood samples
Intervention Type
Device
Intervention Name(s)
bilirubin concentration measured by transcutaneous device
Primary Outcome Measure Information:
Title
Correlation between bilirubin estimates by smartphone pictures and by blood samples
Description
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.
Time Frame
5 minutes
Title
Correlation between bilirubin estimates by smartphone pictures and by transcutaneous measurements
Description
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.
Time Frame
5 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
14 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Siri Forsmo, md prof
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Study Director
Facility Information:
Facility Name
Akershus University Hospital
City
Oslo
Country
Norway
Facility Name
St Olavs Hospital
City
Trondheim
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32267569
Citation
Aune A, Vartdal G, Bergseng H, Randeberg LL, Darj E. Bilirubin estimates from smartphone images of newborn infants' skin correlated highly to serum bilirubin levels. Acta Paediatr. 2020 Dec;109(12):2532-2538. doi: 10.1111/apa.15287. Epub 2020 Apr 19.
Results Reference
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Evaluation of a Smartphone Based Optical Diagnostic Tool for Neonatal Jaundice

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