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Transcutaneous Bilirubinometry in Neonates With the Bilicare System

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ClinicalTrials.gov Identifier: NCT02445755
Recruitment Status : Completed
First Posted : May 15, 2015
Results First Posted : June 4, 2015
Last Update Posted : June 4, 2015
Sponsor:
Information provided by (Responsible Party):
Vinod K. Bhutani, Stanford University

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Transcutaneous Bilirubinometry
Enrollment 113
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Late Preterm and Term Newborns
Hide Arm/Group Description The study population will consist of term and late preterm newborns (infants >=35 weeks gestational age)
Period Title: Overall Study
Started 113 [1]
Completed 100
Not Completed 13
Reason Not Completed
Withdrawal by Subject             2
Protocol Violation             6
Screen Failure             5
[1]
Neonates will be tested with 3 transcutaneous (TcB) devices +/-30 minutes of routine bilirubin labs
Arm/Group Title Late Preterm and Term Newborns
Hide Arm/Group Description The study population will consist of term and late preterm newborns (infants >=35 weeks gestational age)
Overall Number of Baseline Participants 113
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Weeks
Number Analyzed 113 participants
38  (1.25)
[1]
Measure Description: Gestational Age (GA) in weeks
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 113 participants
Female
54
  47.8%
Male
59
  52.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 113 participants
Hispanic or Latino
34
  30.1%
Not Hispanic or Latino
75
  66.4%
Unknown or Not Reported
4
   3.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 113 participants
American Indian or Alaska Native
0
   0.0%
Asian
31
  27.4%
Native Hawaiian or Other Pacific Islander
4
   3.5%
Black or African American
1
   0.9%
White
41
  36.3%
More than one race
0
   0.0%
Unknown or Not Reported
36
  31.9%
1.Primary Outcome
Title 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.
Hide Description [Not Specified]
Time Frame 12 to 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BiliCare TcB BiliCare TcB With Infection Control Tip JM103 TcB Total Serum Bilirubin (TSB)
Hide Arm/Group Description:
The study population will consist of term and late preterm newborns (infants >=35 weeks gestational age) measured with the BiliCare TcB device
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.
The study population will consist of term and late preterm newborns (infants >=35 weeks gestational age) measured with the JM103 TcB device
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.
Overall Number of Participants Analyzed 100 100 97 100
Mean (Standard Deviation)
Unit of Measure: mg/dL
7.5  (2.7) 7.6  (2.9) 6.1  (3.0) 6.4  (3.2)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Late Preterm and Term Newborns
Hide Arm/Group Description The study population will consist of term and late preterm newborns (infants >=35 weeks gestational age)
All-Cause Mortality
Late Preterm and Term Newborns
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Late Preterm and Term Newborns
Affected / at Risk (%)
Total   0/113 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Late Preterm and Term Newborns
Affected / at Risk (%)
Total   0/113 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Name/Title: Vinod K. Bhutani, MD
Organization: Stanford University School of Medicine
Phone: (650) 723-5711
Responsible Party: Vinod K. Bhutani, Stanford University
ClinicalTrials.gov Identifier: NCT02445755     History of Changes
Obsolete Identifiers: NCT02372045
Other Study ID Numbers: 30820
First Submitted: May 13, 2015
First Posted: May 15, 2015
Results First Submitted: May 20, 2015
Results First Posted: June 4, 2015
Last Update Posted: June 4, 2015