Jaundice, NeonatalNCT05630495
Validation of an Innovative Neonatal Jaundice Detection System (Picterus) in Indonesia
A study testing Picterus Jaundice Pro in people with Jaundice, Neonatal, run by Picterus AS at 2 sites in Indonesia.
Trial summary
The long-term goal of this project is to establish Picterus as a permanent tool to detect NNJ in the healthcare services of Indonesia. Offering early detection and therefore, timely treatment to NNJ, will substantially improve neonatal health and directly work towards the Sustainable Development Goal 3.2.2, reduce… 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
- 150 participants
- Where
- 2 sitesIndonesia
- Study dates
- 12 Dec 2022to 15 May 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
- Infants born with gestational age ≥37 weeks Birth weight ≥2000g and ≤4500g Age 1 - 14 days
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
2 sites in 1 country.
Indonesia2 sites, 1 recruiting
- Recruiting
Universitas Airlangga Teaching Hospital
Surabaya, 60115
Mahendra Tri Arif Sampurna, dr., Sp.A(K), PhD, mahendra.tri@fk.unair.ac.id
Mahendra Tri Arif Sampurna, dr., Sp.A(K), PhD
- Completed
RSIA Kendangsari MERR hospital
Surabaya, 60134
About this study
The long-term goal of this project is to establish Picterus as a permanent tool to detect NNJ in the healthcare services of Indonesia. Offering early detection and therefore, timely treatment to NNJ, will substantially improve neonatal health and directly work towards the Sustainable Development Goal 3.2.2, reduce neonatal mortality. The study as the following specific subgoals:
- Demonstrate that Picterus system performs accurately in Indonesian newborns
- Ensure that Picterus is in line with users' needs in Indonesia
Read the detailed description
The long-term goal of this project is to establish Picterus as a permanent tool to detect NNJ in the healthcare services of Indonesia. Offering early detection and therefore, timely treatment to NNJ, will substantially improve neonatal health and directly work towards the Sustainable Development Goal 3.2.2, reduce neonatal mortality. The study as the following specific subgoals:
- Demonstrate that Picterus system performs accurately in Indonesian newborns
- Ensure that Picterus is in line with users' needs in Indonesia
- 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
Use Picterus Jaundice Pro, a smartphone app that is used to take photo of the newborns skin, where the Picterus calibration card is place.
| Study group | Role | What they receive |
|---|---|---|
| Enable high qualitative estimation of bilirubin levels in the blood of new-borns | Experimental | In this study we aim to collect data of newborns with wider range of bilirubin levels and additionally measurements of skin color reflectance with a spectrophotometer, to adjust the Picterus JP algorithm and optimize the app performance. This will enable a high qualitative estimation of bilirubin levels in the blood of new-borns of South-East Asian ethnicity and skin type. 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 Indonesian newborns
Enable high qualitative estimation of bilirubin levels in the blood of Indonesian newborns using Picterus JP.
Measured: 6 months
Secondary outcomes (3)
Correlation with TcB
Correlate the estimates of bilirubin levels obtained by Picterus with TcB
Measured: 5-10 minutes
Correlation with Tsb and TcB
Correlate the estimates of bilirubin levels obtained by Picterus with TSB and TcB
Measured: 1-2 hours
Picterus JP accuracy in Indonesian newborn
Determine the accuracy of Picterus in Indonesian newborns
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study start12 Dec 2022
- Primary completion15 Dec 2023 (estimated)
- Study completion15 May 2024 (estimated)
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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Picterus AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Universitas Airlangga, RSIA Kendangsaru MERR Surabaya
- Responsible party
- Sponsor
- Investigators
- Anders Aune, MD,MPH, Study director, Picterus AS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05630495
- Sponsor's protocol ID
- 2018/1608Indonesia2022
- Status last verified
- Mar 2023
- First submitted
- 8 Nov 2022
- Last updated
- 14 Jul 2023
- 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 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of an Innovative Neonatal Jaundice Detection System (Picterus) in Indonesia
- ClinicalTrials.gov ID
- NCT05630495
- Acronym / sponsor ID
- 2018/1608Indonesia2022
- Conditions
- Jaundice, Neonatal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Picterus ASIndustry (pharma, biotech, devices)
- Collaborators
- Universitas Airlangga, RSIA Kendangsaru MERR Surabaya
- Study start
- 12 Dec 2022 (actual)
- Primary completion
- 15 Dec 2023 (estimated)
- Study completion
- 15 May 2024 (estimated)
- First posted
- 29 Nov 2022 (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 long-term goal of this project is to establish Picterus as a permanent tool to detect NNJ in the healthcare services of Indonesia. Offering early detection and therefore, timely treatment to NNJ, will substantially improve neonatal health and directly work towards the Sustainable Development Goal 3.2.2, reduce neonatal mortality. The study as the following specific subgoals:
- Demonstrate that Picterus system performs accurately in Indonesian newborns
- Ensure that Picterus is in line with users' needs in Indonesia
Detailed description
The long-term goal of this project is to establish Picterus as a permanent tool to detect NNJ in the healthcare services of Indonesia. Offering early detection and therefore, timely treatment to NNJ, will substantially improve neonatal health and directly work towards the Sustainable Development Goal 3.2.2, reduce neonatal mortality. The study as the following specific subgoals:
- Demonstrate that Picterus system performs accurately in Indonesian newborns
- Ensure that Picterus is in line with users' needs in Indonesia
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enable high qualitative estimation of bilirubin levels in the blood of new-borns | Experimental | Device: Picterus Jaundice ProIn this study we aim to collect data of newborns with wider range of bilirubin levels and additionally measurements of skin color reflectance with a spectrophotometer, to adjust the Picterus JP algorithm and optimize the app performance. This will enable a high qualitative estimation of bilirubin levels in the blood of new-borns of South-East Asian ethnicity and skin type. |
Who may qualify
- Ages
- 1 day to 14 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Infants born with gestational age ≥37 weeks Birth weight ≥2000g and ≤4500g Age 1 - 14 days
Key exclusion criteria (2 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 JPUse Picterus Jaundice Pro, a smartphone app that is used to take photo of the newborns skin, where the Picterus calibration card is place. | Device | Enable high qualitative estimation of bilirubin levels in the blood of new-borns |
Primary outcome
Enable high qualitative estimation of bilirubin levels in the blood of Indonesian newborns
Time frame: 6 months
Enable high qualitative estimation of bilirubin levels in the blood of Indonesian newborns using Picterus JP.
3 secondary outcomes
Correlation with TcB
Time frame: 5-10 minutes
Correlation with Tsb and TcB
Time frame: 1-2 hours
Picterus JP accuracy in Indonesian newborn
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2023.
- 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.
Anders Aune, MD,MPH study director
Picterus AS
2 sites 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 2 sites in Indonesia.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 14 Jul 2023. 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 Indonesia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mahendra TA Sampurna, Dr, SP.A (+62 031-5916290, mahendra.tri@fk.unair.ac.id), or a site near the patient. 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 Indonesian newborns (time frame: 6 months). 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 14 Jul 2023.