Evaluation of a Smartphone Based Optical Diagnostic Tool for Neonatal Jaundice
NCT ID: NCT03007563
Last Updated: 2020-04-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
342 participants
INTERVENTIONAL
2017-01-31
2019-03-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Identification of Jaundice in Newborns Using Smartphones
NCT04182555
Development of a Neonatal Jaundice Treatment Accelerator by Redirection of Unused Light During Phototherapy
NCT04021927
Home Based Phototherapy for Neonatal Jaundice
NCT03933423
BUBOLight®, a New Phototherapy Device for the Treatment of the Newborn's Jaundice
NCT04365998
Evaluation of Bilirubin Estimates in Newborns From Smartphone Digital Images in a Nepali Population
NCT05625880
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
newborn infants checked for jaundice
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.
bilirubin concentration estimation from smartphone pictures
pictures taken of the skin covering the breast bone
bilirubin concentration measured in standard blood samples
bilirubin concentration measured by transcutaneous device
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
bilirubin concentration estimation from smartphone pictures
pictures taken of the skin covering the breast bone
bilirubin concentration measured in standard blood samples
bilirubin concentration measured by transcutaneous device
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* born at term
* normal birth weight
Exclusion Criteria
1 Day
14 Days
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Norwegian University of Science and Technology
OTHER
University Hospital, Akershus
OTHER
St. Olavs Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Siri Forsmo, md prof
Role: STUDY_DIRECTOR
Norwegian University of Science and Technology
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Akershus University Hospital
Oslo, , Norway
St Olavs Hospital
Trondheim, , Norway
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2014/619
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.