Jaundice, NeonatalNCT05616845
A mHealth Application as a Screening Tool for Neonatal Jaundice in Filipino Neonates
A study testing Picterus Jaundice Pro in people with Jaundice, Neonatal, run by Picterus AS at 1 site in Philippines.
Trial summary
The purpose of the study is to test the reliability of the Picterus smartphone application in Filipino neonates. A descriptive cross-sectional study will be the method to understand the correlation of the modalities and to determine the reliability of the application 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
- 69 participants
- Where
- 1 sitePhilippines
- Study dates
- 2 Feb 2022to 26 Feb 2022
- 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
- Newborns with or without jaundice
- Gestational age ≥ 37 weeks
- Age 0 - 14 days
- Weight 2500 to 4500 grams
- Absence of congenital malformations
Who cannot join
- Newborns with life-threatening conditions or significant illness
- Newborns diagnosed with inborn errors of metabolism
- Jaundiced newborns that have undergone phototherapy before screening
Trial locations and contacts
1 site in 1 country.
Philippines1 site
Governor Celestino Gallares Memorial Hospital
Tagbilaran City, Bohol, 6300
About this study
The purpose of the study is to test the reliability of the Picterus smartphone application in Filipino neonates. A descriptive cross-sectional study will be the method to understand the correlation of the modalities and to determine the reliability of the application
Read the detailed description
The purpose of the study is to test the reliability of the Picterus smartphone application.
The study is designed for Filipino neonates, but implemented in other LMIC. The participants include newborns with or without jaundice, Gestational age >37 weeks, Age0-14days, Weight >2500 gram and absence of congenital malformations. Demographic data of the neonates will be collected together with all the performed tests and it will be stored in a secured system. Blood will be drawn and measure the bilirubin level of the neonates in a standard clinical routine and will be compared to the estimated bilirubin performed with the Picterus smartphone application.
A descriptive cross-sectional study will be the method to understand the correlation of the modalities and to determine the reliability of the application.
It will provide an answer to whether the Picterus smartphone application is reliable to other populations, especially to darker skin and with high melanin content such as Filipino neonates.
- 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 | There is only one arm in this study which is to enable high qualitative estimation of bilirubin levels in the blood of new-borns with darker skin and with high melanin content such as Filipino neonates. Receives: Device: Picterus Jaundice Pro |
What is being measured
The primary outcome is the main question the study is designed to answer.
validate the reliability of the Picterus mHealth application as a screening tool for neonatal jaundice in Filipino neonates
Validation of smartphone-based screening tool (Picterus JP) for neonatal jaundice in newborns with high melanin content.
Measured: 5-10 minutes
Secondary outcomes (4)
correlation between the estimated levels of bilirubin detected by the Picterus mHealth application and bilirubin serum levels in Filipino neonates
correlation between the estimated levels of bilirubin detected by the Picterus mHealth application and bilirubin serum levels in Filipino neonates
Measured: 1-2 hours
correlation between the estimated level of bilirubin detected by the Picterus mHealth application and transcutaneous bilirubinometer results in Filipino neonates.
correlation between the estimated level of bilirubin detected by the Picterus mHealth application and transcutaneous bilirubinometer results in Filipino neonates.
Measured: 5-10 minutes
correlation between the estimated level of bilirubin detected by the Picterus mHealth application and those obtained using visual Kramer scale in Filipino neonates.
correlation between the estimated level of bilirubin detected by the Picterus mHealth application and those obtained using visual Kramer scale in Filipino neonates.
Measured: 5 minutes
sensitivity, specificity, positive and negative predictive value between estimated bilirubin level of the digital images, Kramer examination and TcB.
sensitivity, specificity, positive and negative predictive value between estimated bilirubin level of the digital images, Kramer examination and TcB.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2022
- Study start2 Feb 2022
- Primary completion26 Feb 2022
- Study completion26 Feb 2022
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
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Picterus AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Norwegian University of Science and Technology, Gov. Celestino Gallares Memorial Hospital
- Responsible party
- Sponsor
- Investigators
- Jon Øyvind Odland, Prof,MD,PhD, Study director, NTNU Faculty of Medicine and Health Sciences, Department of Public Health and Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05616845
- Sponsor's protocol ID
- 322016
- Status last verified
- Nov 2022
- First submitted
- 7 Nov 2022
- Last updated
- 23 Nov 2022
- 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 23 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A mHealth Application as a Screening Tool for Neonatal Jaundice in Filipino Neonates
- ClinicalTrials.gov ID
- NCT05616845
- Acronym / sponsor ID
- 322016
- Conditions
- Jaundice, Neonatal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Picterus ASIndustry (pharma, biotech, devices)
- Collaborators
- Norwegian University of Science and Technology, Gov. Celestino Gallares Memorial Hospital
- Study start
- 2 Feb 2022 (actual)
- Primary completion
- 26 Feb 2022 (actual)
- Study completion
- 26 Feb 2022 (actual)
- First posted
- 15 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 purpose of the study is to test the reliability of the Picterus smartphone application in Filipino neonates. A descriptive cross-sectional study will be the method to understand the correlation of the modalities and to determine the reliability of the application
Detailed description
The purpose of the study is to test the reliability of the Picterus smartphone application.
The study is designed for Filipino neonates, but implemented in other LMIC. The participants include newborns with or without jaundice, Gestational age >37 weeks, Age0-14days, Weight >2500 gram and absence of congenital malformations. Demographic data of the neonates will be collected together with all the performed tests and it will be stored in a secured system. Blood will be drawn and measure the bilirubin level of the neonates in a standard clinical routine and will be compared to the estimated bilirubin performed with the Picterus smartphone application.
A descriptive cross-sectional study will be the method to understand the correlation of the modalities and to determine the reliability of the application.
It will provide an answer to whether the Picterus smartphone application is reliable to other populations, especially to darker skin and with high melanin content such as Filipino neonates.
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 ProThere is only one arm in this study which is to enable high qualitative estimation of bilirubin levels in the blood of new-borns with darker skin and with high melanin content such as Filipino neonates. |
Who may qualify
- Ages
- 1 day to 14 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Newborns with or without jaundice
- Gestational age ≥ 37 weeks
- Age 0 - 14 days
- Weight 2500 to 4500 grams
- Absence of congenital malformations
Key exclusion criteria (3 listed)
- Newborns with life-threatening conditions or significant illness
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
validate the reliability of the Picterus mHealth application as a screening tool for neonatal jaundice in Filipino neonates
Time frame: 5-10 minutes
Validation of smartphone-based screening tool (Picterus JP) for neonatal jaundice in newborns with high melanin content.
4 secondary outcomes
correlation between the estimated levels of bilirubin detected by the Picterus mHealth application and bilirubin serum levels in Filipino neonates
Time frame: 1-2 hours
correlation between the estimated level of bilirubin detected by the Picterus mHealth application and transcutaneous bilirubinometer results in Filipino neonates.
Time frame: 5-10 minutes
correlation between the estimated level of bilirubin detected by the Picterus mHealth application and those obtained using visual Kramer scale in Filipino neonates.
Time frame: 5 minutes
sensitivity, specificity, positive and negative predictive value between estimated bilirubin level of the digital images, Kramer examination and TcB.
Time frame: 5 months
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 23 Nov 2022.
- Master thesis describing the study and its resultsLink provided by the sponsor.
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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.
Jon Øyvind Odland, Prof,MD,PhD study director
NTNU Faculty of Medicine and Health Sciences, Department of Public Health and Nursing
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 Philippines.
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 3 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 23 Nov 2022. 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 Philippines. 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?
validate the reliability of the Picterus mHealth application as a screening tool for neonatal jaundice in Filipino neonates (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 23 Nov 2022.