Jaundice, NeonatalNCT03007563
Evaluation of a Smartphone Based Optical Diagnostic Tool for Neonatal Jaundice
A study testing bilirubin concentration estimation from smartphone pictures, bilirubin concentration measured in standard blood samples and bilirubin concentration measured by transcutaneous device in people with Jaundice, Neonatal and Hyperbilirubinemia, Neonatal, run by St. Olavs Hospital at 2 sites in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 14 days
- Conditions the study is for
- Jaundice, Neonatal, Hyperbilirubinemia, Neonatal
- What is being tested?
- bilirubin concentration estimation from smartphone pictures, bilirubin concentration measured in standard blood samples and bilirubin concentration measured by transcutaneous device
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 342 participants
- Where
- 2 sitesNorway
- Study dates
- Jan 2017to 15 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 14 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- born in St.Olavs hospital, Trondheim or in Akershus hospital, Oslo, Norway
- born at term
- normal birth weight
Who cannot join
- in need of advanced medical treatment
Trial locations and contacts
2 sites in 1 country.
About this study
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
- Being tested
- bilirubin concentration estimation from smartphone pictures, bilirubin concentration measured in standard blood samples, bilirubin concentration measured by transcutaneous device
- Keywords
- Diagnosis, Cell Phones, Infant, Newborn
- Medical subject headings
- Jaundice, Neonatal, Hyperbilirubinemia, Neonatal, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bilirubin concentration estimation from smartphone picturesDevice
pictures taken of the skin covering the breast bone
bilirubin concentration measured in standard blood samplesProcedure or surgery
bilirubin concentration measured by transcutaneous deviceDevice
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: bilirubin concentration estimation from smartphone pictures; Procedure: bilirubin concentration measured in standard blood samples; Device: bilirubin concentration measured by transcutaneous device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2017 (estimated)
- Study startJan 2017
- Primary completion15 Mar 2019
- Study completion15 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Jaundice, NeonatalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 342 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology, University Hospital, Akershus
- Responsible party
- Sponsor
- Investigators
- Siri Forsmo, md prof, Study director, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03007563
- Sponsor's protocol ID
- 2014/619
- Status last verified
- Apr 2020
- First submitted
- 20 Dec 2016
- Last updated
- 13 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32267569
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Smartphone Based Optical Diagnostic Tool for Neonatal Jaundice
- ClinicalTrials.gov ID
- NCT03007563
- Acronym / sponsor ID
- 2014/619
- Conditions
- Jaundice, Neonatal, Hyperbilirubinemia, Neonatal
- Keywords
- Diagnosis, Cell Phones, Infant, Newborn
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 342 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology, University Hospital, Akershus
- Study start
- Jan 2017 (actual)
- Primary completion
- 15 Mar 2019 (actual)
- Study completion
- 15 Mar 2019 (actual)
- First posted
- 2 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| newborn infants checked for jaundice | Experimental | Device: bilirubin concentration estimation from smartphone pictures, Procedure: bilirubin concentration measured in standard blood samples, Device: bilirubin concentration measured by transcutaneous devicean 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. |
Who may qualify
- Ages
- 1 day to 14 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- born in St.Olavs hospital, Trondheim or in Akershus hospital, Oslo, Norway
- born at term
- normal birth weight
Key exclusion criteria (1 listed)
- in need of advanced medical treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bilirubin concentration estimation from smartphone picturespictures taken of the skin covering the breast bone | Device | newborn infants checked for jaundice |
| bilirubin concentration measured in standard blood samples | Procedure or surgery | newborn infants checked for jaundice |
| bilirubin concentration measured by transcutaneous device | Device | newborn infants checked for jaundice |
Primary outcome
Correlation between bilirubin estimates by smartphone pictures and by blood samples
Time frame: 5 minutes
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
Time frame: 5 minutes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2020.
- Results publication: PubMed 32267569Aune 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.
- Individual participant dataSharing planned: No
Related trials for Jaundice, Neonatal
Recruiting
Abdominal Massage for Newborn Jaundice
Neonatal Jaundice
Active, not recruiting
Newborn Abdominal Massage to Prevent Hyperbilirubinemia
Newborn Jaundice
Not yet recruiting
Efficacy of Bifidobacterium Animalis Subsp. Lactis in the Treatment of Indirect Hyperbilirubinemia in Term Neonates
Indirect Hyperbilirubinemia
Not yet recruitingPhase 4
Comparison Of Fenofibrate Vs Phenobarbitone As Adjunct To Phototherapy In Reducing Total Serum Bilirubin In Indirect Hyperbilirubinemia In Neonates
Jaundice, Neonatal
Enrolling by invitation
Hat-Type Glasses Intervention in Phototherapy-Related Newborns
Neonatal Hyperbilirubinemia, Neonatal Jaundice
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Siri Forsmo, md prof study director
Norwegian University of Science and Technology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bilirubin concentration estimation from smartphone pictures, bilirubin concentration measured in standard blood samples and bilirubin concentration measured by transcutaneous device in people with Jaundice, Neonatal and Hyperbilirubinemia, Neonatal, run by St. Olavs Hospital at 2 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between bilirubin estimates by smartphone pictures and by blood samples (time frame: 5 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03007563, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2020.