BiliCam Clinical Validation Study

• Sponsor: BiliCam, LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03246503
• Collaborator: National Institutes of Health (NIH) (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)
• Enrollment: 203
• Location: 1
• Arm: 1
• Actual Duration (Months): 8.3
• Patients Per Site Per Month: 24.5

Study Details

Study Description

Brief 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. BiliCam estimated bilirubin levels will be compared to total serum bilirubin levels in up to 225 newborns.

Condition or Disease	Intervention/Treatment	Phase
Newborn Jaundice	Device: BiliCam estimated bilirubin (BCB)

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 203 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: BiliCam Clinical Validation Study
• Actual Study Start Date: Aug 21, 2017
• Actual Primary Completion Date: Feb 28, 2018
• Actual Study Completion Date: Apr 30, 2018

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Newborns 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.

Device: 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

Outcome Measures

Primary Outcome Measures

1. BCB - TSB Correlation [Newborns up to 192 hours old]

   Pearson correlation coefficient between paired BCB- TSB measurements

Secondary Outcome Measures

1. Intercept of Regression Line [Newborns up to 192 hours old]

   The intercept of the regression line of paired BCB TSB values is reported (BCB is the y-axis and TSB is the x-axis).

2. Slope of Regression Line [Newborns up to 192 hours old]

   The slope of the regression line of paired BCB TSB values is reported (BCB is the y-axis and TSB is the x-axis).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 0 Hours to 191 Hours
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Newborn born at ≥ 35 weeks gestation

• Parent speaks and reads English

• Parent provides written informed consent

Exclusion Criteria:

• previous or ongoing treatment with phototherapy for hyperbilirubinemia

• Medical or other complications that preclude completion of the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Thomas Jefferson University Hopsital	Philadelphia	Pennsylvania	United States	19017

Sponsors and Collaborators

• BiliCam, LLC
• National Institutes of Health (NIH)
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 1, 2017

More Information

Publications

None provided.

• Responsible Party: BiliCam, LLC
• ClinicalTrials.gov Identifier: NCT03246503
• Other Study ID Numbers: 52488; R44HD090778
• First Posted: Aug 11, 2017
• Last Update Posted: Jun 9, 2022
• Last Verified: Jun 1, 2022

• Additional relevant MeSH terms: Jaundice, Neonatal; Jaundice; Bilirubin

Study Results

Participant Flow

Arm/Group Title	Newborns
Arm/Group Description	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. 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
Period Title: Overall Study
STARTED	203
COMPLETED	150
NOT COMPLETED	53

Baseline Characteristics

Arm/Group Title	Newborns
Arm/Group Description	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. 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
Overall Participants	203
Age (hours) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [hours]	95.7 (27.6)
Sex: Female, Male (Count of Participants)
Female	100 49.3%
Male	103 50.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	43 21.2%
Not Hispanic or Latino	160 78.8%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	13 6.4%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	61 30%
White	80 39.4%
More than one race	39 19.2%
Unknown or Not Reported	10 4.9%
Region of Enrollment (participants) [Number]
United States	203 100%

Outcome Measures

1. Primary Outcome

Title	BCB - TSB Correlation
Description	Pearson correlation coefficient between paired BCB- TSB measurements
Time Frame	Newborns up to 192 hours old

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Newborns
Arm/Group Description	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. 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
Measure Participants	144
Number [correlation coefficient]	0.82

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Newborns
	Comments	Bootstrapping with 1000 replications was used to estimate 95% confidence intervals.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<.001
	Comments	statistical significance of Pearson correlation coefficient
	Method	Pearson correlation coefficient
	Comments
Method of Estimation	Estimation Parameter	Pearson correlation coefficient
	Estimated Value	0.82
	Confidence Interval	(2-Sided) 95%; 0.77 to .87
	Parameter Dispersion	Type: Value:
	Estimation Comments	Bootstrapping with 1000 replications was used to estimate 95% confidence intervals.

2. Secondary Outcome

Title	Intercept of Regression Line
Description	The intercept of the regression line of paired BCB TSB values is reported (BCB is the y-axis and TSB is the x-axis).
Time Frame	Newborns up to 192 hours old

Outcome Measure Data

Analysis Population Description

Participants with valid paired BCB and TSB values

Arm/Group Title	Newborns
Arm/Group Description	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. 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
Measure Participants	144
Number (95% Confidence Interval) [mg/dL]	4.13

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Newborns
	Comments
	Type of Statistical Test	Other
	Comments	t-statistic from regression analysis
Statistical Test of Hypothesis	p-Value	<.001
	Comments
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	intercept of regression line
	Estimated Value	4.13
	Confidence Interval	(2-Sided) 95%; 3.35 to 4.91
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Slope of Regression Line
Description	The slope of the regression line of paired BCB TSB values is reported (BCB is the y-axis and TSB is the x-axis).
Time Frame	Newborns up to 192 hours old

Outcome Measure Data

Analysis Population Description

Participants with valid paired BCB and TSB values

Arm/Group Title	Newborns
Arm/Group Description	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. 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
Measure Participants	144
Number (95% Confidence Interval) [slope]	0.68

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Newborns
	Comments
	Type of Statistical Test	Other
	Comments	t-statistic from regression analysis
Statistical Test of Hypothesis	p-Value	<.001
	Comments
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	0.68
	Confidence Interval	(2-Sided) 95%; 0.60 to 0.76
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	Adverse events related to the study device through study completion, for an average of 30 minutes
Arm/Group Title	Newborns
Arm/Group Description	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. 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
All Cause Mortality
	Newborns
	Affected / at Risk (%)	# Events
Total	0/151 (0%)
Serious Adverse Events
	Newborns
	Affected / at Risk (%)	# Events
Total	0/151 (0%)
Other (Not Including Serious) Adverse Events
	Newborns
	Affected / at Risk (%)	# Events
Total	0/151 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.