Neonatal JaundiceNCT05365399
Evaluation of a Smartphone-based Screening Tool for Neonatal Jaundice in a Ugandan Population
A study testing smartphone-based screening tool for neonatal jaundice in people with Neonatal Jaundice, run by Picterus AS at 1 site in Uganda.
Trial summary
The general objective of this study is to evaluate the accuracy of a novel smartphone application that estimates bilirubin levels in newborns at HICH Mbarara. Read more about this study
- Who is it for?
- Ages 24 hours to 14 daysHealthy volunteers can take part
- Conditions the study is for
- Neonatal Jaundice
- What is being tested?
- smartphone-based screening tool for neonatal jaundice
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUganda
- Study dates
- 3 May 2022to 15 Aug 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 24 hours 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
- Infants requiring a blood sample (newborn screening / clinically suspected jaundice)
Who cannot join
- Infants transferred to the paediatric 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 that estimates bilirubin levels in newborns at HICH Mbarara.
Read the detailed description
The general objective of this study is to evaluate the accuracy of a novel smartphone application that estimates bilirubin levels in newborns at HICH Mbarara.
The specific objectives for this study are:
To evaluate the correlation between bilirubin estimates from a smartphone application and bilirubin measurements in serum in newborns with varying degree of jaundice 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 To evaluate the correlation between bilirubin estimates from a smartphone application and bilirubin estimates from visual inspection in newborns with varying degree of jaundice
- Conditions
- Neonatal Jaundice
- Being tested
- smartphone-based screening tool for neonatal jaundice
- Medical subject headings
- Jaundice, Neonatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
smartphone-based screening tool for neonatal jaundiceDevice
In this study we aim to collect data of newborns with wider range of bilirubin levels and high melanin content, 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 for all skin colors. .
| Study group | Role | What they receive |
|---|---|---|
| Enable high qualitative estimation of bilirubin levels in the blood of new-borns | Other | In this study we aim to collect data of newborns with wider range of bilirubin levels and high melanin content, 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 for all skin colors. . Receives: Device: smartphone-based screening tool for neonatal jaundice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smartphone application sensitivity (bilirubin levels on newborns)
Enable high qualitative estimation of bilirubin levels in the blood of newborns, independent of skin color, using Picterus JP.
Measured: 5 minutes
Secondary outcomes (1)
Smartphone application sensitivity (bilirubin levels on newborns with high melanin content) in the skin.
Enable high qualitative estimation of bilirubin levels in the blood of newborns, independent of skin color, using Picterus JP. Adapt the current algorithm of Picterus JP to newborns with high melanin content in the skin
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2022
- Study start3 May 2022
- Primary completion15 Aug 2022
- Study completion15 Aug 2022
Why it stopped: Data collection protocol was not followed-up properly. 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 Neonatal JaundiceStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Picterus AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Norwegian University of Science and Technology
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05365399
- Sponsor's protocol ID
- IS 145
- Status last verified
- Apr 2024
- First submitted
- 28 Apr 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 a Ugandan Population
- ClinicalTrials.gov ID
- NCT05365399
- Acronym / sponsor ID
- IS 145
- Conditions
- Neonatal Jaundice
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Data collection protocol was not followed-up properly. Results are not reliable
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Picterus ASIndustry (pharma, biotech, devices)
- Collaborators
- Norwegian University of Science and Technology
- Study start
- 3 May 2022 (actual)
- Primary completion
- 15 Aug 2022 (actual)
- Study completion
- 15 Aug 2022 (actual)
- First posted
- 9 May 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 general objective of this study is to evaluate the accuracy of a novel smartphone application that estimates bilirubin levels in newborns at HICH Mbarara.
Detailed description
The general objective of this study is to evaluate the accuracy of a novel smartphone application that estimates bilirubin levels in newborns at HICH Mbarara.
The specific objectives for this study are:
To evaluate the correlation between bilirubin estimates from a smartphone application and bilirubin measurements in serum in newborns with varying degree of jaundice 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 To evaluate the correlation between bilirubin estimates from a smartphone application and bilirubin estimates from visual inspection in newborns with varying degree of jaundice
Study design
- Primary purpose
- Diagnosis
- 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 | Other | Device: smartphone-based screening tool for neonatal jaundiceIn this study we aim to collect data of newborns with wider range of bilirubin levels and high melanin content, 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 for all skin colors. . |
Who may qualify
- Ages
- 24 hours to 14 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Infants born with gestational age ≥37 weeks
- Birth weight ≥2000g and ≤4500g
- Age 1 - 14 days
- Infants requiring a blood sample (newborn screening / clinically suspected jaundice)
Key exclusion criteria (4 listed)
- Infants transferred to the paediatric 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 |
|---|---|---|
| smartphone-based screening tool for neonatal jaundiceIn this study we aim to collect data of newborns with wider range of bilirubin levels and high melanin content, 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 for all skin colors. . | Device | Enable high qualitative estimation of bilirubin levels in the blood of new-borns |
Primary outcome
Smartphone application sensitivity (bilirubin levels on newborns)
Time frame: 5 minutes
Enable high qualitative estimation of bilirubin levels in the blood of newborns, independent of skin color, using Picterus JP.
1 secondary outcome
Smartphone application sensitivity (bilirubin levels on newborns with high melanin content) in the skin.
Time frame: 5 minutes
Results and safety
The study was stopped early (reason given: Data collection protocol was not followed-up properly. 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing smartphone-based screening tool for neonatal jaundice in people with Neonatal Jaundice, run by Picterus AS at 1 site in Uganda.
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 1 site in Uganda. 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: Data collection protocol was not followed-up properly. 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?
Smartphone application sensitivity (bilirubin levels on newborns) (time frame: 5 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.