Jaundice, NeonatalNCT04182555
Identification of Jaundice in Newborns Using Smartphones
A study testing Bilirubin estimates from Smartphone Application, Bilirubin concentration measured in standard blood samples and Bilirubin estimates from standard 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 estimates from Smartphone Application, Bilirubin concentration measured in standard blood samples and Bilirubin estimates from standard transcutaneous device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 2 sitesNorway
- Study dates
- 3 Aug 2020to 15 Sep 2020
- 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 Haugesund Hospital, Norway
- Born with gestational age >36+6
- Birth weight ≥ 2500g and <4500g
- Age 1 - <15 days
- Are having a blood sample performed, as newborn screening or for jaundice assessment
Who cannot join
- Infants needing intensive treatment. This includes:
- Infants in the need for respiratory support
- Infants with conditions that could compromise skin circulation, as sepsis, heart failure or other
- Infants that have received phototherapy
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 was developed and tested in a pilot study and the application refined.
This smartphone application will now be evaluated in a clinical trial set in two hospitals in Norway. The smartphone application gives immediate estimates of bilirubin values in newborns, and these estimates will be compared to the bilirubin levels measured in standard blood samples, as well as the results from ordinary transcutaneous measurement devices.
Read the detailed description
The smartphone jaundice app system works by taking pictures of newborns with a custom-made color calibration card placed on their chest. This makes it possible to measure the skin color precisely regardless of the specific light source that is used to illuminate the newborn. The measured skin color is then compared with items in a database of simulated newborn skin colors. These simulated newborn skin colors have been created using numerical simulations of how light moves through skin, with varying skin parameters including, but not limited to, skin thickness, blood concentration, melanin, and of course bilirubin, the pigment that causes jaundice. By comparing the measured skin color with the simulated skin colors that are most similar to it, the investigators can then estimate the bilirubin concentration in the newborn's skin by e.g. averaging the bilirubin concentrations used to create these simulated skin colors.
In a group of 200 newborns with varying degree of jaundice, correlation between smartphone bilirubin estimates will be compared with total serum bilirubin and standard transcutaneous bilirubinometry.
- Conditions
- Jaundice, Neonatal, Hyperbilirubinemia, Neonatal
- Being tested
- Bilirubin estimates from Smartphone Application, Bilirubin concentration measured in standard blood samples, Bilirubin estimates from standard transcutaneous device, Visual assessment of jaundice
- Keywords
- Diagnosis, Cell Phones, Infant, Newborn, Skin Pigmentation
- Medical subject headings
- Jaundice, Neonatal, Hyperbilirubinemia, Neonatal, Disease, Pigmentation Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilirubin estimates from Smartphone ApplicationDevice
Bilirubin estimates through color analysis of digital images obtained through smartphone application.
Bilirubin concentration measured in standard blood samplesDiagnostic test
Bilirubin measured in total serum bilirubin.
Bilirubin estimates from standard transcutaneous deviceDevice
Bilirubin estimates performed by transcutaneous device ( Dräger JM-105)
Visual assessment of jaundiceOther
Degree of jaundice will be assessed by Kramer scale
| Study group | Role | What they receive |
|---|---|---|
| Newborns in St.Olavs Hospital and Haugesund Hospital | Experimental | All newborns will be examined through 4 different methods of determining jaundice. Receives: Device: Bilirubin estimates from Smartphone Application; Diagnostic Test: Bilirubin concentration measured in standard blood samples; Device: Bilirubin estimates from standard transcutaneous device; Other: Visual assessment of jaundice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smartphone application sensitivity
Sensitivity of the smartphone application to detect severe jaundice, defined as total serum bilirubin value > 250 umol/l.
Measured: 5 minutes
Secondary outcomes (4)
Repeatability
To evaluate the repeatability of multiple measurements with the new smartphone tool
Measured: 5 min
Correlation between bilirubin estimates by smartphone pictures and by total serum bilirubin
Estimate of bilirubin levels from smartphone pictures, compared with bilirubin measurements in total serum. Correlation will be expressed by Pearson correlation coefficient, r.
Measured: 5 minutes
Correlation between bilirubin estimates by smartphone pictures and by standard transcutaneous readings.
To evaluate the correlation between bilirubin estimates from a smartphone application and bilirubin estimates from a standard transcutaneous device in newborns with varying degree of jaundice. Correlation will be expressed by Pearson correlation coefficient, r.
Measured: 5 minutes
Correlation between bilirubin estimates by smartphone pictures and visual assessment of jaundice
- To evaluate the correlation between bilirubin estimates from a smartphone application and bilirubin estimates from visual inspection in newborns with varying degree of jaundice
Measured: 5 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2019
- Study start3 Aug 2020
- Primary completion15 Sep 2020
- Study completion15 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Jaundice, NeonatalStudies of the same condition, open and under way.
- More trials run by St. Olavs HospitalThe sponsor's other registered studies.
- 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 200 newborns with varying degree of jaundice will be recruited.
- Masking
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology, Helse Fonna
- Responsible party
- Sponsor
- Investigators
- Siri Forsmo, md prof, Study director, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04182555
- Sponsor's protocol ID
- 2018/1608
- Status last verified
- Sep 2022
- First submitted
- 27 Nov 2019
- Last updated
- 26 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Jaundice in Newborns Using Smartphones
- ClinicalTrials.gov ID
- NCT04182555
- Acronym / sponsor ID
- 2018/1608
- Conditions
- Jaundice, Neonatal, Hyperbilirubinemia, Neonatal
- Keywords
- Diagnosis, Cell Phones, Infant, Newborn, Skin Pigmentation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology, Helse Fonna
- Study start
- 3 Aug 2020 (actual)
- Primary completion
- 15 Sep 2020 (actual)
- Study completion
- 15 Sep 2020 (actual)
- First posted
- 2 Dec 2019 (actual)
- 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 was developed and tested in a pilot study and the application refined.
This smartphone application will now be evaluated in a clinical trial set in two hospitals in Norway. The smartphone application gives immediate estimates of bilirubin values in newborns, and these estimates will be compared to the bilirubin levels measured in standard blood samples, as well as the results from ordinary transcutaneous measurement devices.
Detailed description
The smartphone jaundice app system works by taking pictures of newborns with a custom-made color calibration card placed on their chest. This makes it possible to measure the skin color precisely regardless of the specific light source that is used to illuminate the newborn. The measured skin color is then compared with items in a database of simulated newborn skin colors. These simulated newborn skin colors have been created using numerical simulations of how light moves through skin, with varying skin parameters including, but not limited to, skin thickness, blood concentration, melanin, and of course bilirubin, the pigment that causes jaundice. By comparing the measured skin color with the simulated skin colors that are most similar to it, the investigators can then estimate the bilirubin concentration in the newborn's skin by e.g. averaging the bilirubin concentrations used to create these simulated skin colors.
In a group of 200 newborns with varying degree of jaundice, correlation between smartphone bilirubin estimates will be compared with total serum bilirubin and standard transcutaneous bilirubinometry.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 200 newborns with varying degree of jaundice will be recruited.
| Arm | Type | Receives |
|---|---|---|
| Newborns in St.Olavs Hospital and Haugesund Hospital | Experimental | Device: Bilirubin estimates from Smartphone Application, Diagnostic Test: Bilirubin concentration measured in standard blood samples, Device: Bilirubin estimates from standard transcutaneous device, Other: Visual assessment of jaundiceAll newborns will be examined through 4 different methods of determining jaundice. |
Who may qualify
- Ages
- 1 day to 14 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Born in St.Olavs hospital, Trondheim or in Haugesund Hospital, Norway
- Born with gestational age >36+6
- Birth weight ≥ 2500g and <4500g
- Age 1 - <15 days
- Are having a blood sample performed, as newborn screening or for jaundice assessment
Key exclusion criteria (4 listed)
- Infants in the need for respiratory support
- Infants with conditions that could compromise skin circulation, as sepsis, heart failure or other
- Infants that have received phototherapy
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 estimates from Smartphone ApplicationBilirubin estimates through color analysis of digital images obtained through smartphone application. | Device | Newborns in St.Olavs Hospital and Haugesund Hospital |
| Bilirubin concentration measured in standard blood samplesBilirubin measured in total serum bilirubin. | Diagnostic test | Newborns in St.Olavs Hospital and Haugesund Hospital |
| Bilirubin estimates from standard transcutaneous deviceBilirubin estimates performed by transcutaneous device ( Dräger JM-105) | Device | Newborns in St.Olavs Hospital and Haugesund Hospital |
| Visual assessment of jaundiceDegree of jaundice will be assessed by Kramer scale | Other | Newborns in St.Olavs Hospital and Haugesund Hospital |
Primary outcome
Smartphone application sensitivity
Time frame: 5 minutes
Sensitivity of the smartphone application to detect severe jaundice, defined as total serum bilirubin value > 250 umol/l.
4 secondary outcomes
Repeatability
Time frame: 5 min
Correlation between bilirubin estimates by smartphone pictures and by total serum bilirubin
Time frame: 5 minutes
Correlation between bilirubin estimates by smartphone pictures and by standard transcutaneous readings.
Time frame: 5 minutes
Correlation between bilirubin estimates by smartphone pictures and visual assessment of jaundice
Time frame: 5 min
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 26 Sep 2022.
- 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 estimates from Smartphone Application, Bilirubin concentration measured in standard blood samples and Bilirubin estimates from standard 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 5 inclusion and 4 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 26 Sep 2022. 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?
Smartphone application sensitivity (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Sep 2022.