Trial Outcomes & Findings for BiliCam Clinical Validation Study (NCT NCT03246503)

NCT ID: NCT03246503

Last Updated: 2022-06-09

Results Overview

Pearson correlation coefficient between paired BCB- TSB measurements

• Recruitment status: COMPLETED
• Target enrollment: 203 participants
• Primary outcome timeframe: Newborns up to 192 hours old
• Results posted on: 2022-06-09

Participant Flow

Participant milestones

Measure	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. 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 Study STARTED	203
Overall Study COMPLETED	150
Overall Study NOT COMPLETED	53

Reasons for withdrawal

Measure	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. 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 Study Lost to Follow-up	23
Overall Study Withdrawal by Subject	20
Overall Study Physician Decision	5
Overall Study Received phtototherapy prior to study visit=4, blood specimen not obtained =1	5

Baseline Characteristics

A total of 203 participants were consented. Age was not obtained until the study visit; 150 participants had a study visit

Baseline characteristics by cohort

Measure	Newborns n=203 Participants 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
Age, Continuous	95.7 hours STANDARD_DEVIATION 27.6 • n=150 Participants • A total of 203 participants were consented. Age was not obtained until the study visit; 150 participants had a study visit
Sex: Female, Male Female	100 Participants n=203 Participants
Sex: Female, Male Male	103 Participants n=203 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	43 Participants n=203 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	160 Participants n=203 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=203 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=203 Participants
Race (NIH/OMB) Asian	13 Participants n=203 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=203 Participants
Race (NIH/OMB) Black or African American	61 Participants n=203 Participants
Race (NIH/OMB) White	80 Participants n=203 Participants
Race (NIH/OMB) More than one race	39 Participants n=203 Participants
Race (NIH/OMB) Unknown or Not Reported	10 Participants n=203 Participants
Region of Enrollment United States	203 participants n=203 Participants

PRIMARY outcome

Timeframe: Newborns up to 192 hours old

Population: 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.

Pearson correlation coefficient between paired BCB- TSB measurements

Outcome measures

Measure

Newborns n=144 Participants 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

BCB - TSB Correlation

0.82 correlation coefficient

SECONDARY outcome

Timeframe: Newborns up to 192 hours old

Population: Participants with valid paired BCB and TSB values

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

Outcome measures

Measure

Newborns n=144 Participants 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

Intercept of Regression Line

4.13 mg/dL Interval 3.35 to 4.91

SECONDARY outcome

Timeframe: Newborns up to 192 hours old

Population: Participants with valid paired BCB and TSB values

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

Outcome measures

Measure

Newborns n=144 Participants 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

Slope of Regression Line

0.68 slope Interval 0.6 to 0.76

Adverse Events

Newborns

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

James Taylor

BiliCam, LLC

Phone: 2064194923

Email: uncjat@google.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place