Trial Outcomes & Findings for Transcutaneous Bilirubinometry in Neonates With Bilicare System (NCT NCT02372058)

Last Updated: 2015-09-11

Results Overview

Recruitment status

COMPLETED

Study phase

Target enrollment

103 participants

Primary outcome timeframe

30 minutes within taking the blood draw for TSB (either before or after the blood draw)

Results posted on

2015-09-11

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	103
Overall Study COMPLETED	100
Overall Study NOT COMPLETED	3

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	3

Transcutaneous Bilirubinometry in Neonates With Bilicare System

Baseline characteristics by cohort
Measure	Late Preterm and Term Newborns n=100 Participants The study population will consist of term and late preterm newborns (infants \>=35 weeks gestational age)
Age, Continuous	43.5 Hours since birth STANDARD_DEVIATION 19.75 • n=5 Participants
Sex: Female, Male Female	57 Participants n=5 Participants
Sex: Female, Male Male	43 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	23 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	75 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	49 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	33 Participants n=5 Participants

Timeframe: 30 minutes within taking the blood draw for TSB (either before or after the blood draw)

Outcome measures
Measure	BiliCare TcB Average n=100 Participants The study population will consist of term and late preterm newborns (infants \>=35 weeks gestational age) measured with one BiliCare TcB device without an infection control tip and with one BiliCare TcB device with an infection control tip. This is the average of both devices	JM103 TcB n=100 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.
BiliCare TcB Result Compared to TSB Result	8.46 mg/dL Standard Deviation 2.68	7.93 mg/dL Standard Deviation 3.48	7.83 mg/dL Standard Deviation 3.27

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

Albert Einstein Medical Center located in Philadelphia, Pennsylvania, USA

Phone: 215-456-6698