Efficacy Study of the Draeger Jaundice Meter (JM-105) in Neonates of ≥ 24 Weeks of Gestational Age
|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: NCT02774434|
Recruitment Status : Completed
First Posted : May 17, 2016
Last Update Posted : February 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hyperbilirubinemia Neonatal Jaundice||Device: JM-105||Not Applicable|
Hyperbilirubinemia is a condition that occurs in newborns when there is too much bilirubin in the blood. It is the most common cause of newborns being readmitted to the hospital. It may be harmless or harmful depending on what the cause is and how bad it is. The serum level of bilirubin required for jaundice varies with infants skin tones and body region, however jaundice usually becomes visible in the white part of the eye at smaller levels. Although jaundice in newborn is generally not harmful, it is important to monitor newborns to identify those that are at risk of developing a neurological dysfunction from high bilirubin levels. As part of standard of care all hospitalized newborns are routinely monitored for the development of jaundice by nursing staff and physicians every 8-12 hours. Although jaundice in newborns can usually be detected by lightening/whitening in the skin with digital pressure, this method of visual estimation is very inaccurate and unreliable. Transcutaneous bilirubin measurements are non-invasive and has proven to be equivalent to total serum bilirubin measurements. The JM-103 has been proven to be an effective TcB measure in ethnically diverse populations for patients >35 weeks gestational age. The JM-105 has been upgraded from the JM-103 with greater efficiency and accuracy. The basic function is the same but has been improved with a larger touch screen, data storage and transmission functionality.
This prospective multi-centre study will be conducted to determine the diagnostic accuracy and performance of the use of the JM-105 in providing transcutaneous bilirubin measurements to estimate serum total bilirubin in neonates ≥ 24 weeks of gestational age who have or have not undergone phototherapy. The study will compare each of the measurements of transcutaneous bilirubin (TcB) obtained for 10 days via the JM-105 device with a neonatology team-ordered series of serum total bilirubin (TSB) measured by high-performance liquid chromatography.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||464 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy Study of the Draeger Jaundice Meter (JM-105) in Providing TcB Measurements to Estimate TSB in Neonates of ≥ 24 Weeks of Gestational Age Who Have and Have Not Undergone Phototherapy|
|Actual Study Start Date :||November 2016|
|Actual Primary Completion Date :||June 2018|
|Actual Study Completion Date :||June 2018|
Within 15 minutes of each ordered blood sample 2 TcB measurements will be performed using the JM-105 on the sternum and forehead. Subject's participation will end after a 10 day period.
Measurement of TcB via the JM-105 device
- Accuracy of TcB measured with the JM-105 device in predicting the Serum Bilirubin measurements performed on blood samples [ Time Frame: Within 15 minutes of blood sample taking ]Primary objective is to determine the accuracy of TcB measured with the JM-105 device in predicting the Serum Bilirubin measurements performed on blood samples from heel sticks or from peripheral line in neonates ≥ 24 weeks of gestational Age who are currently undergoing or have undergone phototherapy as a Screening and Monitoring device for hyperbilirubinemia
- Normalized curve of TSB measurements using the JM-105 [ Time Frame: Within 15 minutes of blood sample taking ]The secondary objective is to determine a normalized curve of TSB measurements using the JM-105.
- Influence of phototherapy on TSB measurements [ Time Frame: Within 15 minutes of blood sample taking ]The Impact of phototherapy on TSB measurements will be explored.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02774434
|Saint Michael's Hospital|
|Toronto, Ontario, Canada, M5B1W8|
|Mount Sinai Hospital|
|Toronto, Ontario, Canada, M5G 1X5|
|Hamilton Health Science Centre|
|Toronto, Ontario, Canada|
|Principal Investigator:||Michael Sgro, MD||St. Michael's Hospital, Toronto|