Trial Outcomes & Findings for Transcutaneous Bilirubinometry in Neonates With the BiliCare System Compared to the Invasive TSB Test (NCT NCT02372071)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

111 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	Preterm, Late Preterm and Term Newborns The study population will consist of preterm, late preterm and term newborns (infants \>=24 weeks gestational age)
Overall Study STARTED	111
Overall Study COMPLETED	93
Overall Study NOT COMPLETED	18

Reasons for withdrawal
Measure	Preterm, Late Preterm and Term Newborns The study population will consist of preterm, late preterm and term newborns (infants \>=24 weeks gestational age)
Overall Study Protocol Violation	18

Transcutaneous Bilirubinometry in Neonates With the BiliCare System Compared to the Invasive TSB Test

Baseline characteristics by cohort
Measure	Preterm, Late Preterm and Term Newborns n=93 Participants The study population will consist of preterm, late preterm and term newborns (infants \>=24 weeks gestational age)
Age, Customized 24<=Gestational Age [weeks]<35	33.2 Weeks STANDARD_DEVIATION 2.0 • n=99 Participants
Age, Customized 35<=Gestational Age [weeks]	38.9 Weeks STANDARD_DEVIATION 1.8 • n=99 Participants
Sex: Female, Male Female	45 Participants n=99 Participants
Sex: Female, Male Male	48 Participants n=99 Participants
Race/Ethnicity, Customized Caucasian (White or Tan skin tone))	93 participants n=99 Participants
Race/Ethnicity, Customized African or Bedouin (Dark Skin tone)	0 participants n=99 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=93 Participants The study population will consist of preterm, late preterm and term newborns (infants \>=24 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	Total Serum Bilirubin (TSB) n=93 Participants The study population will consist of preterm, late preterm and term newborns (infants \>=24 weeks gestational age) measured routinely for total serum bilirubin
BiliCare TcB Result Compared to TSB Result	8.0 mg/dL Standard Deviation 4.4	7.3 mg/dL Standard Deviation 3.9

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

Hadassah Hospital located in Jerusalem, Israel

Phone: 02-6774919