Jaundice, NeonatalNCT05625880
Evaluation of Bilirubin Estimates in Newborns From Smartphone Digital Images in a Nepali Population
A study testing Picterus Jaundice Pro in people with Jaundice, Neonatal, run by Picterus AS at 1 site in Nepal.
Trial summary
This cross-sectional study evaluates the accuracy of a novel smartphone application that estimates bilirubin levels in newborns at Dhulikhel Hospital, Kathmandu Nepal. 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
- 200 participants
- Where
- 1 siteNepal
- Study dates
- 1 Jun 2019to 6 Aug 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 day to 14 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infants born with gestational age ≥35 weeks
- Birth weight ≥ 1750g
- Age 1 - ≤14 days
- Infants that will have a blood sample draw
Who cannot join
- Infants in the need for respiratory support
- Infants with conditions that could compromise skin circulation, as sepsis, heart failure
- Infants that have received phototherapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Bilirubin Estimates in Newborns From Smartphone Digital Images in a Nepali Population at Dhulikhel Hospital, Kathmandu University Hospital.
This cross-sectional study evaluates the accuracy of a novel smartphone application that estimates bilirubin levels in newborns at Dhulikhel Hospital, Kathmandu Nepal.
Read the detailed description
This cross-sectional study evaluates the accuracy of a novel smartphone application that estimates bilirubin levels in 200 newborns at Dhulikhel Hospital, Kathmandu Nepal. 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
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 using Picterus JP. 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 newborns at Dhulikhel Hospital, Kathmandu Nepal.
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 hours
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 posted23 Nov 2022
- Study start1 Jun 2019
- Primary completion28 Jun 2019
- Study completion6 Aug 2019
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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Picterus AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- St. Olavs Hospital, Dhulikhel Hospital, National Taiwan Normal University
- Responsible party
- Principal investigator, Anders Aune, Picterus AS
- Investigators
- Sunila Shakya, MD, PhD, Principal investigator, Dhulikhel Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05625880
- Sponsor's protocol ID
- 2018/1608Nepal
- Status last verified
- Nov 2022
- First submitted
- 10 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
- Evaluation of Bilirubin Estimates in Newborns From Smartphone Digital Images in a Nepali Population at Dhulikhel Hospital, Kathmandu University Hospital.
- ClinicalTrials.gov ID
- NCT05625880
- Acronym / sponsor ID
- 2018/1608Nepal
- Conditions
- Jaundice, Neonatal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Picterus ASIndustry (pharma, biotech, devices)
- Collaborators
- St. Olavs Hospital, Dhulikhel Hospital, National Taiwan Normal University
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 28 Jun 2019 (actual)
- Study completion
- 6 Aug 2019 (actual)
- First posted
- 23 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.
This cross-sectional study evaluates the accuracy of a novel smartphone application that estimates bilirubin levels in newborns at Dhulikhel Hospital, Kathmandu Nepal.
Detailed description
This cross-sectional study evaluates the accuracy of a novel smartphone application that estimates bilirubin levels in 200 newborns at Dhulikhel Hospital, Kathmandu Nepal. 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 ProThere is only one arm in this study which is to enable high qualitative estimation of bilirubin levels in the blood of new-borns using Picterus JP. |
Who may qualify
- Ages
- 1 day to 14 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Infants born with gestational age ≥35 weeks
- Birth weight ≥ 1750g
- Age 1 - ≤14 days
- Infants that will have a blood sample draw
Key exclusion criteria (3 listed)
- Infants in the need for respiratory support
- Infants with conditions that could compromise skin circulation, as sepsis, heart failure
- 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 |
|---|---|---|
| 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 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 newborns at Dhulikhel Hospital, Kathmandu Nepal.
3 secondary outcomes
correlation between bilirubin estimates in from a smartphone application and bilirubin measurements in serum in newborn
Time frame: 1-2 hours
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 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.
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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.
Sunila Shakya, MD, PhD principal investigator
Dhulikhel 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 Nepal.
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 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 Nepal. 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, 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 23 Nov 2022.