Neonatal JaundiceNCT06329843
Intermountain Inpatient Bilirubin Decision Accuracy Study Using Smartphone-based Measurements by Picterus Jaundice Pro
An observational study of Neonatal Jaundice, run by Picterus AS at 1 site in United States.
Trial summary
The goal of this project is to evaluate the performance of Picterus Jaundice Pro in an American population, including preterm and term newborns and pre- and post- phototherapy. Read more about this study
- Who is it for?
- Ages 12 to 192 hoursHealthy volunteers can take part
- Conditions the study is for
- Neonatal Jaundice
- What is being tested?
- Picterus Jaundice Pro (JP)
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2024to May 2024
- Phase
- Observational
- 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 12 to 192 hours
- All sexes
- Healthy volunteers accepted
- Child
Study population: newborns
Who may be able to join
- the patient is free of skin rash, bruising, or other medical conditions that can interfere with transcutaneous measurement
- (preterm) < = 35 weeks gestational age
- (term) > 35 weeks gestational age
- the patient has not been excluded by PI discretion.
Who cannot join
- Neonates will be excluded from participation if all four inclusion criteria listed above are not met.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Intermountain Health
Salt Lake City, Utah, 84132
Timothy M Bahr, MS MD, 801-602-6523, Tim.Bahr@imail.org
Kimberlee W Lewis, MS RN, 801.507.7675, [kimberlee.weaverlewis@imail.org
About this study
The goal of this project is to evaluate the performance of Picterus Jaundice Pro in an American population, including preterm and term newborns and pre- and post- phototherapy.
Read the detailed description
The purpose of this study is to compare serum bilirubin levels with non-invasive bilirubin measurements in neonates during the first 12 to 192 hours of life using the "Picterus Jaundice Pro" smartphone application with a proprietary calibration card placed over the neonate's sternum. We will also validate the accuracy of Picterus Jaundice Pro bilirubin measurements before and after phototherapy treatment.
- Conditions
- Neonatal Jaundice
- Being tested
- Picterus Jaundice Pro (JP)
- Keywords
- jaundice, neonate, phototherapy
- Medical subject headings
- Jaundice, Neonatal, Jaundice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Picterus Jaundice Pro (JP)Device
Picterus Jaundice Pro photos will be obtained of enrolled subjects each time the patient has a serum bilirubin level obtained. Up to five paired measurements will be obtained per enrolled subject. The study nurse will place the proprietary calibration card over the subject's sternum and take six Picterus Jaundice Pro photos using a study iPhone within one hour of the serum bilirubin draw. This process takes less than one minute. After the study photos are obtained, the study nurse will record the serum and Picterus Jaundice Pro values in the data-recording log.
In the event an enrolled infant requires phototherapy, a light occlusive adhesive patch will be placed over the center of the chest before phototherapy initiation. When a serum bilirubin level is obtained, the research nurse will remove the patch for a brief moment to take Picterus Jaundice Pro pictures (within one hour of the serum value draw).
| Study group | Role | What they receive |
|---|---|---|
| Term-born babies & preterm born babies | We will collect 300 paired (serum bilirubin and Picterus Jaundice Pro) measurements on eligible neonates >35 weeks' gestation admitted to a well-baby nursery. Of these, 150 paired measurements will be from neonates who have already received phototherapy (either on phototherapy or status/post phototherapy) and had a light-occlusive adhesive skin patch in place. Each subject >35 weeks gestation can have up to 5 measurements during the study.
We will collect 200 paired (serum bilirubin and Picterus) measurements on eligible neonates <35 weeks gestation. Of these, 100 paired measurements will be from neonates who have already received phototherapy (either on phototherapy or status/post phototherapy) and had a light-occlusive adhesive skin patch in place. Each subject <35 weeks gestation can have up to 5 measurements during the study. Receives: Device: Picterus Jaundice Pro (JP) |
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 term and preterm newborns undergoing phototherapy using Picterus JP.
Evaluate Picterus JP to screen for neonatal jaundice in term and preterm newborns undergoing phototherapy and use the results to improve the analysis algorithm for this population
Measured: 2 months
Secondary outcomes (4)
Correlate the bilirubin measurement from Picterus JP with serum bilirubin levels from term-born babies without phototherapy.
Evaluate the correlation between Picterus JP bilirubin measurements and blood serum measurements in term-born babies without phototherapy.
Measured: 2 hours
Correlate the bilirubin measurement from Picterus JP with serum bilirubin levels from preterm-born babies without phototherapy.
Evaluate the correlation between Picterus JP bilirubin measurements and blood serum measurements in preterm-born babies without phototherapy.
Measured: 2 hours
Correlate the bilirubin measurement from Picterus JP with serum bilirubin levels from term-born babies who have received phototherapy.
Evaluate the correlation between Picterus JP bilirubin measurements and blood serum measurements in term-born babies who have received phototherapy.
Measured: 2 hours
Correlate the bilirubin measurement from Picterus JP with serum bilirubin levels from preterm-born babies who have received phototherapy.
Evaluate the correlation between Picterus JP bilirubin measurements and blood serum measurements in preterm-born babies who have received phototherapy.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start12 Feb 2024
- Primary completionMay 2024 (estimated)
- Study completionMay 2024 (estimated)
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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Picterus AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Intermountain Health Care, Inc.
- Responsible party
- Sponsor
- Investigators
- Timothy M Bahr, MS MD, Principal investigator, Intermountain Health Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06329843
- Sponsor's protocol ID
- Intermountain
- Status last verified
- Mar 2024
- First submitted
- 7 Feb 2024
- Last updated
- 26 Mar 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 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermountain Inpatient Bilirubin Decision Accuracy Study Using Smartphone-based Measurements by Picterus Jaundice Pro
- ClinicalTrials.gov ID
- NCT06329843
- Acronym / sponsor ID
- Intermountain
- Conditions
- Neonatal Jaundice
- Keywords
- jaundice, neonate, phototherapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Picterus ASIndustry (pharma, biotech, devices)
- Collaborators
- Intermountain Health Care, Inc.
- Study start
- 12 Feb 2024 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 26 Mar 2024 (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 goal of this project is to evaluate the performance of Picterus Jaundice Pro in an American population, including preterm and term newborns and pre- and post- phototherapy.
Detailed description
The purpose of this study is to compare serum bilirubin levels with non-invasive bilirubin measurements in neonates during the first 12 to 192 hours of life using the "Picterus Jaundice Pro" smartphone application with a proprietary calibration card placed over the neonate's sternum. We will also validate the accuracy of Picterus Jaundice Pro bilirubin measurements before and after phototherapy treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Term-born babies & preterm born babies | – | Device: Picterus Jaundice Pro (JP)We will collect 300 paired (serum bilirubin and Picterus Jaundice Pro) measurements on eligible neonates >35 weeks' gestation admitted to a well-baby nursery. Of these, 150 paired measurements will be from neonates who have already received phototherapy (either on phototherapy or status/post phototherapy) and had a light-occlusive adhesive skin patch in place. Each subject >35 weeks gestation can have up to 5 measurements during the study. We will collect 200 paired (serum bilirubin and Picterus) measurements on eligible neonates <35 weeks gestation. Of these, 100 paired measurements will be from neonates who have already received phototherapy (either on phototherapy or status/post phototherapy) and had a light-occlusive adhesive skin patch in place. Each subject <35 weeks gestation can have up to 5 measurements during the study. |
Who may qualify
- Ages
- 12 to 192 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- newborns
Key inclusion criteria (4 listed)
- the patient is free of skin rash, bruising, or other medical conditions that can interfere with transcutaneous measurement
- (preterm) < = 35 weeks gestational age
- (term) > 35 weeks gestational age
- the patient has not been excluded by PI discretion.
Key exclusion criteria (1 listed)
- Neonates will be excluded from participation if all four inclusion criteria listed above are not met.
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 Pro (JP)Picterus Jaundice Pro photos will be obtained of enrolled subjects each time the patient has a serum bilirubin level obtained. Up to five paired measurements will be obtained per enrolled subject. The study nurse will place the proprietary calibration card over the subject's sternum and take six Picterus Jaundice Pro photos using a study iPhone within one hour of the serum bilirubin draw. This process takes less than one minute. After the study photos are obtained, the study nurse will record the serum and Picterus Jaundice Pro values in the data-recording log. In the event an enrolled infant requires phototherapy, a light occlusive adhesive patch will be placed over the center of the chest before phototherapy initiation. When a serum bilirubin level is obtained, the research nurse will remove the patch for a brief moment to take Picterus Jaundice Pro pictures (within one hour of the serum value draw). | Device | Term-born babies & preterm born babies |
Primary outcome
Enable high qualitative estimation of bilirubin levels in the blood of term and preterm newborns undergoing phototherapy using Picterus JP.
Time frame: 2 months
Evaluate Picterus JP to screen for neonatal jaundice in term and preterm newborns undergoing phototherapy and use the results to improve the analysis algorithm for this population
4 secondary outcomes
Correlate the bilirubin measurement from Picterus JP with serum bilirubin levels from term-born babies without phototherapy.
Time frame: 2 hours
Correlate the bilirubin measurement from Picterus JP with serum bilirubin levels from preterm-born babies without phototherapy.
Time frame: 2 hours
Correlate the bilirubin measurement from Picterus JP with serum bilirubin levels from term-born babies who have received phototherapy.
Time frame: 2 hours
Correlate the bilirubin measurement from Picterus JP with serum bilirubin levels from preterm-born babies who have received phototherapy.
Time frame: 2 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 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.
Timothy M Bahr, MS MD principal investigator
Intermountain Health Care, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Jaundice, run by Picterus AS at 1 site in United States.
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 1 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 26 Mar 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 United States. 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 Timothy M Bahr, MS MD (801-602-6523, Tim.Bahr@imail.org), 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 term and preterm newborns undergoing phototherapy using Picterus JP. (time frame: 2 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 26 Mar 2024.