NCT03007563

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
342

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2016

Completed
12 days until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 2, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2019

Completed
Last Updated

April 13, 2020

Status Verified

April 1, 2020

Enrollment Period

2.2 years

First QC Date

December 20, 2016

Last Update Submit

April 9, 2020

Conditions

Jaundice, NeonatalHyperbilirubinemia, Neonatal

Keywords

DiagnosisCell PhonesInfant, Newborn

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (1)

newborn infants checked for jaundice

EXPERIMENTAL

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 picturesProcedure: bilirubin concentration measured in standard blood samplesDevice: bilirubin concentration measured by transcutaneous device

Interventions

bilirubin concentration estimation from smartphone picturesDEVICE

pictures taken of the skin covering the breast bone

newborn infants checked for jaundice
bilirubin concentration measured in standard blood samplesPROCEDURE
newborn infants checked for jaundice
bilirubin concentration measured by transcutaneous deviceDEVICE
newborn infants checked for jaundice

Eligibility Criteria

Age1 Day - 14 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • born in St.Olavs hospital, Trondheim or in Akershus hospital, Oslo, Norway
  • born at term
  • normal birth weight

You may not qualify if:

  • in need of advanced medical treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Akershus University Hospital

Oslo, Norway

Location

St Olavs Hospital

Trondheim, Norway

Location

Related Publications (1)

  • 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.

    PMID: 32267569RESULT

MeSH Terms

Conditions

Jaundice, NeonatalHyperbilirubinemia, NeonatalDisease

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHyperbilirubinemiaPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Siri Forsmo, md prof

    Norwegian University of Science and Technology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2016

First Posted

January 2, 2017

Study Start

January 1, 2017

Primary Completion

March 15, 2019

Study Completion

March 15, 2019

Last Updated

April 13, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

NO(2)