Trial Outcomes & Findings for Transcutaneous Bilirubinometry in Neonates With the Bilicare System (NCT NCT02445755)

NCT ID: NCT02445755

Last Updated: 2015-06-04

Results Overview

• Recruitment status: COMPLETED
• Target enrollment: 113 participants
• Primary outcome timeframe: 12 to 48 hours
• Results posted on: 2015-06-04

Participant Flow

Participant milestones

Measure	Late Preterm and Term Newborns The study population will consist of term and late preterm newborns (infants \>=35 weeks gestational age)
Overall Study STARTED	113
Overall Study COMPLETED	100
Overall Study NOT COMPLETED	13

Reasons for withdrawal

Measure	Late Preterm and Term Newborns The study population will consist of term and late preterm newborns (infants \>=35 weeks gestational age)
Overall Study Withdrawal by Subject	2
Overall Study Protocol Violation	6
Overall Study Screen Failure	5

Baseline Characteristics

Transcutaneous Bilirubinometry in Neonates With the Bilicare System

Baseline characteristics by cohort

Measure	Late Preterm and Term Newborns n=113 Participants The study population will consist of term and late preterm newborns (infants \>=35 weeks gestational age)
Age, Continuous	38 Weeks STANDARD_DEVIATION 1.25 • n=93 Participants
Sex: Female, Male Female	54 Participants n=93 Participants
Sex: Female, Male Male	59 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	34 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	75 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	31 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	4 Participants n=93 Participants
Race (NIH/OMB) Black or African American	1 Participants n=93 Participants
Race (NIH/OMB) White	41 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	36 Participants n=93 Participants

PRIMARY outcome

Timeframe: 12 to 48 hours

Outcome measures

Measure	BiliCare TcB n=100 Participants The study population will consist of term and late preterm newborns (infants \>=35 weeks gestational age) measured with the BiliCare TcB device	BiliCare TcB With Infection Control Tip n=100 Participants The study population will consist of term and late preterm newborns (infants \>=35 weeks gestational age) measured with the BiliCare TcB device with infection control tip.	JM103 TcB n=97 Participants The study population will consist of term and late preterm newborns (infants \>=35 weeks gestational age) measured with the JM103 TcB device	Total Serum Bilirubin (TSB) n=100 Participants The study population will consist of term and late preterm newborns (infants \>=35 weeks gestational age) measured routinely for total serum bilirubin by diazo method.
In This Study, the Investigators Plan to Test the Performance of a Novel Transcutaneous Device (BiliCareTM) to Screen for Bilirubin Levels at Postnatal Age of 12 to 48 Hours.	7.5 mg/dL Standard Deviation 2.7	7.6 mg/dL Standard Deviation 2.9	6.1 mg/dL Standard Deviation 3.0	6.4 mg/dL Standard Deviation 3.2

Adverse Events

Late Preterm and Term 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

Vinod K. Bhutani, MD

Stanford University School of Medicine

Phone: (650) 723-5711

Email: bhutani@stanford.edu

Results disclosure agreements

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