Jaundice, NeonatalNCT05623566
Evaluation of a Smartphone Based Screening Tool for Neonatal Jaundice in Surabaya, Indonesia
A study testing Picterus Jaundice Pro in people with Jaundice, Neonatal, run by Picterus AS at 3 sites in Indonesia.
Trial summary
A cross-sectional conductive study aiming to evaluate the accuracy of a novel smartphone application that estimates bilirubin levels in newborns in Surabaya. Read more about this study
- Who is it for?
- Ages 1 hour 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
- 284 participants
- Where
- 3 sitesIndonesia
- Study dates
- 29 Nov 2018to 29 Apr 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 hour to 14 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infants born with gestational age >31
- Birth weight ≥ 1500g
- Age 0 - ≤14 days
- Consent obtained from the parents
Who cannot join
- Infants born with congenital abnormalities;
- Infants respiratory support;
- Infants suffering from a condition that may alter the skin tissue circulatory system, such as sepsis and heart failure;
- Infants who have received phototherapy in the last 24 hours.
Trial locations and contacts
3 sites in 1 country.
Indonesia3 sites
Airlangga University hospital
Surabaya, East Java, 60115
RSIA Kendangsari MERR
Surabaya, East Java, 60134
Dr. Soetomo General Hospital
Surabaya, East Java, 60286
About this study
A cross-sectional conductive study aiming to evaluate the accuracy of a novel smartphone application that estimates bilirubin levels in newborns in Surabaya.
Read the detailed description
A cross-sectional conductive study aiming to evaluate the accuracy of a novel smartphone application that estimates bilirubin levels in newborns at Airlangga University hospital and RSIA Kendangsari MERR in Surabaya.
This cross-sectional study evaluates the accuracy of a novel smartphone application that estimates bilirubin levels in Indonesian newborns. The Picterus Calibration Card was placed on the chest of the newborn with the hole in the card placed over the infant's sternum. A validated smartphone with Picterus JP was used to collect digital images.
- 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
In this study we aim to collect data of newborns with wider range of bilirubin levels 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 for all skin colors.
| 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 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 for all skin colors. 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, independent of skin color, using Picterus JP.
Evaluate of smartphone-based screening tool (Picterus JP) for neonatal jaundice in Indonesian newborns.
Measured: 5-10 minutes
Secondary outcomes (3)
Correlation between bilirubin estimates in from a smartphone application and bilirubin measurements in serum in newborn
To evaluate the correlation between bilirubin estimates in from a smartphone application and bilirubin measurements in serum in newborns with varying degree of jaundice
Measured: 1-2 minutes
correlation between bilirubin estimates from a smartphone application and bilirubin estimates from a standard transcutaneous device in newborns
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
Measured: 5-10 minutes
Correlation between bilirubin estimates from a smartphone application and bilirubin estimates from visual inspection in newborns
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: 5-10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2022
- Study start29 Nov 2018
- Primary completion29 Nov 2018
- Study completion29 Apr 2019
Why it stopped: After data quality check, inclusion criteria were not satisfied and data quality was poor. We concluded that results are not reliable
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
- 284 participants (actual)
Sponsor and investigators
- Lead sponsor
- Picterus AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- RSIA Kendangsaru Surabaya, Universitas Airlangga
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05623566
- Sponsor's protocol ID
- 2018/1608Indonesia
- Status last verified
- Apr 2024
- First submitted
- 10 Nov 2022
- Last updated
- 4 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Smartphone Based Screening Tool for Neonatal Jaundice in Surabaya, Indonesia
- ClinicalTrials.gov ID
- NCT05623566
- Acronym / sponsor ID
- 2018/1608Indonesia
- Conditions
- Jaundice, Neonatal
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: After data quality check, inclusion criteria were not satisfied and data quality was poor. We concluded that results are not reliable
- Enrolment
- 284 participants (actual)
- Lead sponsor
- Picterus ASIndustry (pharma, biotech, devices)
- Collaborators
- RSIA Kendangsaru Surabaya, Universitas Airlangga
- Study start
- 29 Nov 2018 (actual)
- Primary completion
- 29 Nov 2018 (actual)
- Study completion
- 29 Apr 2019 (actual)
- First posted
- 21 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.
A cross-sectional conductive study aiming to evaluate the accuracy of a novel smartphone application that estimates bilirubin levels in newborns in Surabaya.
Detailed description
A cross-sectional conductive study aiming to evaluate the accuracy of a novel smartphone application that estimates bilirubin levels in newborns at Airlangga University hospital and RSIA Kendangsari MERR in Surabaya.
This cross-sectional study evaluates the accuracy of a novel smartphone application that estimates bilirubin levels in Indonesian newborns. The Picterus Calibration Card was placed on the chest of the newborn with the hole in the card placed over the infant's sternum. A validated smartphone with Picterus JP was used to collect digital images.
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 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 for all skin colors. |
Who may qualify
- Ages
- 1 hour to 14 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Infants born with gestational age >31
- Birth weight ≥ 1500g
- Age 0 - ≤14 days
- Consent obtained from the parents
Key exclusion criteria (4 listed)
- Infants born with congenital abnormalities;
- Infants respiratory support;
- Infants suffering from a condition that may alter the skin tissue circulatory system, such as sepsis and heart failure;
- Infants who have received phototherapy in the last 24 hours.
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 JPIn this study we aim to collect data of newborns with wider range of bilirubin levels 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 for all skin colors. | 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 newborns, independent of skin color, using Picterus JP.
Time frame: 5-10 minutes
Evaluate of smartphone-based screening tool (Picterus JP) for neonatal jaundice in Indonesian newborns.
3 secondary outcomes
Correlation between bilirubin estimates in from a smartphone application and bilirubin measurements in serum in newborn
Time frame: 1-2 minutes
correlation between bilirubin estimates from a smartphone application and bilirubin estimates from a standard transcutaneous device in newborns
Time frame: 5-10 minutes
Correlation between bilirubin estimates from a smartphone application and bilirubin estimates from visual inspection in newborns
Time frame: 5-10 minutes
Results and safety
The study was stopped early (reason given: After data quality check, inclusion criteria were not satisfied and data quality was poor. We concluded that results are not reliable). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 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 3 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 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: stopped early, as of the sponsor's last update on 4 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 3 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?
The study was stopped early (reason given: After data quality check, inclusion criteria were not satisfied and data quality was poor. We concluded that results are not reliable). Results are not available in the source record.
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, independent of skin color, using Picterus JP. (time frame: 5-10 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 4 Apr 2024.