Newborn JaundiceNCT03246503

BiliCam Clinical Validation Study

A study testing BiliCam estimated bilirubin (BCB) in people with Newborn Jaundice, run by BiliCam, LLC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The goal of this study is to assess the accuracy of BiliCam, a non-invasive technology based on analysis of digital images obtained with an app installed on a commercial smartphone, in estimating total serum bilirubin levels in newborns. Read more about this study

Who is it for?: Ages 0 to 191 hoursHealthy volunteers can take part
Conditions the study is for: Newborn Jaundice
What is being tested?: BiliCam estimated bilirubin (BCB)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 203 participants
Where: 1 siteUnited States
Study dates: 21 Aug 2017to 30 Apr 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 0 to 191 hours
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Newborn born at ≥ 35 weeks gestation
Parent speaks and reads English
Parent provides written informed consent

Who cannot join

previous or ongoing treatment with phototherapy for hyperbilirubinemia
Medical or other complications that preclude completion of the study

Trial locations and contacts

1 site in 1 country.

United States1 site

Thomas Jefferson University Hopsital
Philadelphia, Pennsylvania, 19017

Other trials in United States

About this study

Read the detailed description

Jaundice, a yellowing of the skin and eyes caused by a build up of bilirubin in the blood, is a common problem in newborn infants. Measurement of total serum bilirubin (TSB) levels is used for clinical decision making. BiliCam is a non-invasive technology used to estimate TSB levels in newborns. With BiliCam, the user obtains digital images of a small portion of a newborn's skin using the BiliCam app installed on a commercial smartphone in a standardized manner. A color calibration card is placed on the baby's sternum to account for varying light conditions. Data on color levels in the photos are used to estimate a bilirubin level.

For the study, paired BiliCam estimated bilirubin (BCB) and TSB levels will be compared on a racially and ethnically diverse sample of newborns. Recruitment will continue until 225 newborns have completed the study.

Conditions: Newborn Jaundice
Being tested: BiliCam estimated bilirubin (BCB)
Medical subject headings: Jaundice, Neonatal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BiliCam estimated bilirubin (BCB)Device
Images will be obtained using the BiliCam app installed on a commercial smartphone and used to calculated a BCB level. The BCB levels will be used for study purposes only and not used for clinical care

Study groups in NCT03246503
Study group	Role	What they receive
Newborns	Experimental	Newborns will be enrolled in the study in 2 different ways. At "Staged Enrollment" sites, newborns will be enrolled when they are < 48 hours old. These newborns will have a study visit when they are 48 - 167 hours old. At the study visit, a BCB will be determined and blood will be drawn for study purposes for a TSB level. At "Simultaneous Enrollment" sites, newborns will be enrolled and have a study visit at the time of a blood draw (+/- 2 hours) for a TSB level that is being obtained for clinical purposes. Newborns will be 0-191 hours old. Receives: Device: BiliCam estimated bilirubin (BCB)

What is being measured

The primary outcome is the main question the study is designed to answer.

BCB - TSB Correlation
Pearson correlation coefficient between paired BCB- TSB measurements
Measured: Newborns up to 192 hours old

Secondary outcomes (2)

Intercept of Regression Line
The intercept of the regression line of paired BCB TSB values is reported (BCB is the y-axis and TSB is the x-axis).
Measured: Newborns up to 192 hours old
Slope of Regression Line
The slope of the regression line of paired BCB TSB values is reported (BCB is the y-axis and TSB is the x-axis).
Measured: Newborns up to 192 hours old

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Aug 201730 Apr 2018

First posted11 Aug 2017
Study start21 Aug 2017
Primary completion28 Feb 2018
Study completion30 Apr 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Newborn 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
Primary purpose: Screening
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 203 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03246503
Sponsor's protocol ID: 52488
Other IDs: R44HD090778
Status last verified: Jun 2022
First submitted: 8 Aug 2017
Last updated: 9 Jun 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Abdominal Massage for Newborn Jaundice
Neonatal Jaundice
Active, not recruiting
Newborn Abdominal Massage to Prevent Hyperbilirubinemia
Newborn Jaundice
Not yet recruiting
Efficacy of Bifidobacterium Animalis Subsp. Lactis in the Treatment of Indirect Hyperbilirubinemia in Term Neonates
Indirect Hyperbilirubinemia
Not yet recruitingPhase 4
Comparison Of Fenofibrate Vs Phenobarbitone As Adjunct To Phototherapy In Reducing Total Serum Bilirubin In Indirect Hyperbilirubinemia In Neonates
Jaundice, Neonatal
Enrolling by invitation
Hat-Type Glasses Intervention in Phototherapy-Related Newborns
Neonatal Hyperbilirubinemia, Neonatal Jaundice

All Newborn Jaundice trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: BiliCam Clinical Validation Study
ClinicalTrials.gov ID: NCT03246503
Acronym / sponsor ID: 52488
Conditions: Newborn Jaundice
Study type: Interventional
Recruitment status: Completed
Enrolment: 203 participants (actual)
Lead sponsor: BiliCam, LLCIndustry (pharma, biotech, devices)
Collaborators: National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study start: 21 Aug 2017 (actual)
Primary completion: 28 Feb 2018 (actual)
Study completion: 30 Apr 2018 (actual)
First posted: 11 Aug 2017 (actual)
Results: Posted 9 Jun 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Screening
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Newborns	Experimental	Device: BiliCam estimated bilirubin (BCB)Newborns will be enrolled in the study in 2 different ways. At "Staged Enrollment" sites, newborns will be enrolled when they are < 48 hours old. These newborns will have a study visit when they are 48 - 167 hours old. At the study visit, a BCB will be determined and blood will be drawn for study purposes for a TSB level. At "Simultaneous Enrollment" sites, newborns will be enrolled and have a study visit at the time of a blood draw (+/- 2 hours) for a TSB level that is being obtained for clinical purposes. Newborns will be 0-191 hours old.

Who may qualify

Ages: 0 to 191 hours
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (3 listed)

Newborn born at ≥ 35 weeks gestation
Parent speaks and reads English
Parent provides written informed consent

Key exclusion criteria (2 listed)

previous or ongoing treatment with phototherapy for hyperbilirubinemia
Medical or other complications that preclude completion of the study

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
BiliCam estimated bilirubin (BCB)Images will be obtained using the BiliCam app installed on a commercial smartphone and used to calculated a BCB level. The BCB levels will be used for study purposes only and not used for clinical care	Device	Newborns

Primary outcome

BCB - TSB Correlation
Time frame: Newborns up to 192 hours old
Pearson correlation coefficient between paired BCB- TSB measurements

2 secondary outcomes

Intercept of Regression Line
Time frame: Newborns up to 192 hours old
Slope of Regression Line
Time frame: Newborns up to 192 hours old

Results and safety

Results posted to the registry on 9 Jun 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Newborns	203	150

Primary outcome: BCB - TSB Correlation

Time frame: Newborns up to 192 hours old. Number. Unit: correlation coefficient

Measure	Newborns n = 144
Value	0.82

Newborns: Pearson correlation coefficient: 0.82 (95% CI 0.77 to .87), p <.001, Pearson correlation coefficient

Population analysed: Participants who completed study visit and had valid paired TSB-BCB results. There were 3 participants in whom blood was obtained for TSB levels, but no valid measurement was available (1 grossly hemolyzed sample, 1 specimen lost, and 1 specimen not obtained within 2 hours of the BCB level). There were 3 participants in whom a BCB level could not be obtained by the study device.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events related to the study device through study completion, for an average of 30 minutes. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Newborns	0 of 151 (0%)	0 of 151 (0%)	0 of 151

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Newborn Jaundice

Recruiting
Abdominal Massage for Newborn Jaundice
Neonatal Jaundice
Active, not recruiting
Newborn Abdominal Massage to Prevent Hyperbilirubinemia
Newborn Jaundice
Not yet recruiting
Efficacy of Bifidobacterium Animalis Subsp. Lactis in the Treatment of Indirect Hyperbilirubinemia in Term Neonates
Indirect Hyperbilirubinemia
Not yet recruitingPhase 4
Comparison Of Fenofibrate Vs Phenobarbitone As Adjunct To Phototherapy In Reducing Total Serum Bilirubin In Indirect Hyperbilirubinemia In Neonates
Jaundice, Neonatal
Enrolling by invitation
Hat-Type Glasses Intervention in Phototherapy-Related Newborns
Neonatal Hyperbilirubinemia, Neonatal Jaundice

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 BiliCam estimated bilirubin (BCB) in people with Newborn Jaundice, run by BiliCam, LLC 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 3 inclusion and 2 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 9 Jun 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 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?

Yes. Results are posted in the registry (first posted 9 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

BCB - TSB Correlation (time frame: Newborns up to 192 hours old). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03246503.

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 9 Jun 2022.