Jaundice, NeonatalNCT06372093
Evaluation of Bilirubin Measurements in Newborns From Smartphone Digital Images in a Population in Botswana
A study testing Picterus Jaundice Pro in people with Jaundice, Neonatal, run by Picterus AS at 1 site in Botswana.
Trial summary
The general objective of this study is to evaluate the accuracy of a novel smartphone application for jaundice screening (Picterus Jaundice Pro) in a population with high melanin content in the skin. The specific objectives for this study are: i. Read more about this study
- Who is it for?
- Ages 1 day to 14 daysHealthy volunteers can take part
- Conditions the study is for
- Jaundice, Neonatal
- What is being tested?
- Picterus Jaundice Pro
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteBotswana
- Study dates
- 16 Mar 2023to 26 Feb 2024
- 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
- Healthy volunteers accepted
- Child
Who may be able to join
- Gestational age > 37 weeks
- Birth weight > 2000 g and < 4500 g
- Age 1-14 days
- Infants requiring a blood sample for clinically suspected jaundice/screening
Who cannot join
- Infants transferred to the pediatric ward for advanced treatment.
- Infants with a skin rash or other disease that affects the skin where measurements are performed.
- Infants that receive or have received phototherapy in the last 24 hours.
- Infants with an inborn disease.
Trial locations and contacts
1 site in 1 country.
About this study
The general objective of this study is to evaluate the accuracy of a novel smartphone application for jaundice screening (Picterus Jaundice Pro) in a population with high melanin content in the skin.
The specific objectives for this study are:
- To assess the correlation between bilirubin level measurements obtained by Picterus Jaundice Pro with Total Serum Bilirubin (TSB), and TcB, in newborns with high melanin content in the skin. ii. To determine the accuracy of Picterus Jaundice Pro in newborns with high melanin content in the skin.
Read the detailed description
The goal for this project is to demonstrate that the Picterus Jaundice Pro screening method can be used to identify children with severe neonatal jaundice independent of skin color. Thus, providing a cheaper, patient-friendly, and more readily available method of neonatal jaundice detection. The long-term goal is that with the implementation of the app, the identification of newborns with severe jaundice will be improved and, thus, referred at an earlier stage for diagnostics and treatment.
The study will be a cross-sectional study with quantitative methods of data collection.
The study population will comprise 150 newborns from the Neonatal Unit and the maternity ward at Princess Marina Hospital.
Parents to newborns with and without signs of jaundice will be asked to participate.
Following informed consent, background data such as birth weight, age on examination, gestational age, and type of feeding will be obtained. Gestational age will be based on ultrasound determination and the last normal menstruation period (LNMP). The skin type of the infant will be classified according to the newborn Neomar's scale score.
Transcutaneous bilirubin measurements will be performed over the sternum of the infant. A Dräger Jaundice Meter JM-105 will be used in this study. Skin reflectance will be measured using a portable Konica Minolta spectrophotometer CM-700d.
A validated smartphone with Picterus Jaundice Pro will be used to collect digital images of skin of the infant chest together with the Picterus calibration card. After all the images are obtained, a unique ID will be displayed on the smartphone. This ID will be recorded on the case report forms and later used to pair clinical data and digital images.
A blood sample to determine TSB will be obtained within 60 minutes of obtaining the images and processed at the Department of clinical biochemistry in the hospital laboratory.
After completion of the study the bilirubin measurement from Picterus Jaundice Pro will be determined and compared to the TSB and TCB measurements using the Pearson correlation coefficient. Sub-analysis for the different skin colors will be performed. Systematic over- or under-estimation of bilirubin levels will be evaluated using Bland-Altman plots. Sensitivity and specificity analysis will be calculated for different cut-off values (ROC analysis).
- Conditions
- Jaundice, Neonatal
- Being tested
- Picterus Jaundice Pro
- Medical subject headings
- Jaundice, Neonatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Picterus Jaundice ProDevice
Also called Picterus JP
Picterus Jaundice Pro is a smartphone based screening tool for neonatal jaundice that takes images of the skin of the newborn chest where the Picterus Calibration Card is placed.
| Study group | Role | What they receive |
|---|---|---|
| Enable reliable measurement of bilirubin levels in the blood of newborns | Experimental | to enable reliable measurement of bilirubin levels in the blood of newborns independent of skin color Receives: Device: Picterus Jaundice Pro |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enable high qualitative estimation of bilirubin levels in the blood of newborns in a population in Botswana using Picterus JP.
Evaluate of smartphone-based screening tool (Picterus JP) for neonatal jaundice in newborns with high melanin content.
Measured: 1 year
Secondary outcomes (2)
Correlation of bilirubin levels obtained by Picterus JP with Tsb and TcB
Correlate estimates of bilirubin levels obtained by Picterus JP with TSB and TcB in newborns with high melanin content in the skin.
Measured: 1-2 hours
Sensitivity and specificity of Picterus JP to detect jaundice in newborns with high melanin content in the skin
Determine the sensitivity and specificity of Picterus JP to screen for jaundice in newborns with high melanin content in the skin
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start16 Mar 2023
- Primary completion26 Feb 2024
- Study completion26 Feb 2024
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.
- 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
- Masking
- None (open label)
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Picterus AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Copenhagen, University of Botswana
- Responsible party
- Sponsor
- Investigators
- Julie Zimmer, Principal investigator, University of CopenhagueBritt Nakstad, MD, PhD, MSC, Study director, Princess Marina Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06372093
- Sponsor's protocol ID
- PMH 2/11AII
- Status last verified
- Apr 2024
- First submitted
- 22 Jan 2024
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- 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 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Bilirubin Measurements in Newborns From Smartphone Digital Images in a Population in Botswana
- ClinicalTrials.gov ID
- NCT06372093
- Acronym / sponsor ID
- PMH 2/11AII
- Conditions
- Jaundice, Neonatal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Picterus ASIndustry (pharma, biotech, devices)
- Collaborators
- University of Copenhagen, University of Botswana
- Study start
- 16 Mar 2023 (actual)
- Primary completion
- 26 Feb 2024 (actual)
- Study completion
- 26 Feb 2024 (actual)
- First posted
- 17 Apr 2024 (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.
The general objective of this study is to evaluate the accuracy of a novel smartphone application for jaundice screening (Picterus Jaundice Pro) in a population with high melanin content in the skin.
The specific objectives for this study are:
- To assess the correlation between bilirubin level measurements obtained by Picterus Jaundice Pro with Total Serum Bilirubin (TSB), and TcB, in newborns with high melanin content in the skin. ii. To determine the accuracy of Picterus Jaundice Pro in newborns with high melanin content in the skin.
Detailed description
The goal for this project is to demonstrate that the Picterus Jaundice Pro screening method can be used to identify children with severe neonatal jaundice independent of skin color. Thus, providing a cheaper, patient-friendly, and more readily available method of neonatal jaundice detection. The long-term goal is that with the implementation of the app, the identification of newborns with severe jaundice will be improved and, thus, referred at an earlier stage for diagnostics and treatment.
The study will be a cross-sectional study with quantitative methods of data collection.
The study population will comprise 150 newborns from the Neonatal Unit and the maternity ward at Princess Marina Hospital.
Parents to newborns with and without signs of jaundice will be asked to participate.
Following informed consent, background data such as birth weight, age on examination, gestational age, and type of feeding will be obtained. Gestational age will be based on ultrasound determination and the last normal menstruation period (LNMP). The skin type of the infant will be classified according to the newborn Neomar's scale score.
Transcutaneous bilirubin measurements will be performed over the sternum of the infant. A Dräger Jaundice Meter JM-105 will be used in this study. Skin reflectance will be measured using a portable Konica Minolta spectrophotometer CM-700d.
A validated smartphone with Picterus Jaundice Pro will be used to collect digital images of skin of the infant chest together with the Picterus calibration card. After all the images are obtained, a unique ID will be displayed on the smartphone. This ID will be recorded on the case report forms and later used to pair clinical data and digital images.
A blood sample to determine TSB will be obtained within 60 minutes of obtaining the images and processed at the Department of clinical biochemistry in the hospital laboratory.
After completion of the study the bilirubin measurement from Picterus Jaundice Pro will be determined and compared to the TSB and TCB measurements using the Pearson correlation coefficient. Sub-analysis for the different skin colors will be performed. Systematic over- or under-estimation of bilirubin levels will be evaluated using Bland-Altman plots. Sensitivity and specificity analysis will be calculated for different cut-off values (ROC analysis).
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enable reliable measurement of bilirubin levels in the blood of newborns | Experimental | Device: Picterus Jaundice Proto enable reliable measurement of bilirubin levels in the blood of newborns independent of skin color |
Who may qualify
- Ages
- 1 day to 14 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Gestational age > 37 weeks
- Birth weight > 2000 g and < 4500 g
- Age 1-14 days
- Infants requiring a blood sample for clinically suspected jaundice/screening
Key exclusion criteria (4 listed)
- Infants transferred to the pediatric ward for advanced treatment.
- Infants with a skin rash or other disease that affects the skin where measurements are performed.
- Infants that receive or have received phototherapy in the last 24 hours.
- Infants with an inborn disease.
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 |
|---|---|---|
| Picterus Jaundice ProAlso: Picterus JPPicterus Jaundice Pro is a smartphone based screening tool for neonatal jaundice that takes images of the skin of the newborn chest where the Picterus Calibration Card is placed. | Device | Enable reliable measurement of bilirubin levels in the blood of newborns |
Primary outcome
Enable high qualitative estimation of bilirubin levels in the blood of newborns in a population in Botswana using Picterus JP.
Time frame: 1 year
Evaluate of smartphone-based screening tool (Picterus JP) for neonatal jaundice in newborns with high melanin content.
2 secondary outcomes
Correlation of bilirubin levels obtained by Picterus JP with Tsb and TcB
Time frame: 1-2 hours
Sensitivity and specificity of Picterus JP to detect jaundice in newborns with high melanin content in the skin
Time frame: 1 year
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 17 Apr 2024.
- Individual participant dataSharing planned: No
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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.
Julie Zimmer principal investigator
University of Copenhague
Britt Nakstad, MD, PhD, MSC study director
Princess Marina Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Picterus Jaundice Pro in people with Jaundice, Neonatal, run by Picterus AS at 1 site in Botswana.
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 4 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 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Botswana. 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?
Enable high qualitative estimation of bilirubin levels in the blood of newborns in a population in Botswana using Picterus JP. (time frame: 1 year). 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 17 Apr 2024.