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Transcutaneous Bilirubinometry in Neonates With Bilicare System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02372058
Recruitment Status : Completed
First Posted : February 26, 2015
Results First Posted : September 11, 2015
Last Update Posted : September 11, 2015
Sponsor:
Information provided by (Responsible Party):
Gerium Medical

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Screening
Condition We Will Focus on Assessing the Clinical Performance of the BiliCare Device
Intervention Device: BiliCare
Enrollment 103
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 103
Completed 100
Not Completed 3
Reason Not Completed
Withdrawal by Subject             3
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 100
Hide Baseline Analysis Population Description
Number of participants who completed the study
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Hours since birth
Number Analyzed 100 participants
43.5  (19.75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants
Female
57
  57.0%
Male
43
  43.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants
Hispanic or Latino
23
  23.0%
Not Hispanic or Latino
75
  75.0%
Unknown or Not Reported
2
   2.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants
American Indian or Alaska Native
0
   0.0%
Asian
4
   4.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
49
  49.0%
White
14
  14.0%
More than one race
0
   0.0%
Unknown or Not Reported
33
  33.0%
1.Primary Outcome
Title BiliCare TcB Result Compared to TSB Result
Hide Description [Not Specified]
Time Frame 30 minutes within taking the blood draw for TSB (either before or after the blood draw)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BiliCare TcB Average 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 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

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 100 100 100
Mean (Standard Deviation)
Unit of Measure: mg/dL
8.46  (2.68) 7.93  (3.48) 7.83  (3.27)
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   --/-- 
Hide Serious Adverse Events
Late Preterm and Term Newborns
Affected / at Risk (%)
Total   0/100 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Late Preterm and Term Newborns
Affected / at Risk (%)
Total   0/100 (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
Layout table for Results Point of Contact information
Name/Title: Dr. David L. Schutzman
Organization: Albert Einstein Medical Center located in Philadelphia, Pennsylvania, USA
Phone: 215-456-6698
EMail: schutzmand@einstein.edu
Layout table for additonal information
Responsible Party: Gerium Medical
ClinicalTrials.gov Identifier: NCT02372058    
Other Study ID Numbers: 10002
First Submitted: February 22, 2015
First Posted: February 26, 2015
Results First Submitted: August 13, 2015
Results First Posted: September 11, 2015
Last Update Posted: September 11, 2015