Efficacy Study of the Draeger Jaundice Meter (JM-105) in Neonates of ≥ 24 Weeks of Gestational Age
Efficacy Study of the Draeger Jaundice Meter (JM-105) in Neonates of ≥ 24 Weeks of Gestational Age
The Canadian Pediatric Society recently published guidelines to monitor bilirubin levels and
 as part of standard of care all hospitalized newborns are routinely monitored for the
 development of high bilirubin or jaundice every 8-12 hours. One device approved and used in
 both Canada and the United States is the Draeger Jaundice Meter JM-103, a non-invasive
 medical device. It has been proven to be effective in patients >35 weeks gestational age.
 Recently the JM-103 has been upgraded to include a bigger touch screen, greater storage and
 functionality. The rest of the features of the JM-103 and JM-105 are identical. In order to
 test the accuracy of the JM-105 neonates from ≥ 24 weeks gestational age who have or have not
 undergone phototherapy will be prospectively monitored for transcutaneous bilirubin (TcB)
 using the JM-105. The measurements will be compared to a physician-ordered total serum
 bilirubin (TSB).
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.
Inclusion Criteria:

 -  The subject is a neonate ≥24 weeks of gestational age for whom a course of
 phototherapy has not started, is in progress or has been completed

 -  The subject's routine management includes TSB evaluations

 -  The subject's family are willing and able to participate in baseline and TSB
 measurements over 10 days

 -  Written informed consent to participate in the study has been provided by the subject
 or legal representative (parent or legal guardian in a clinical study involving
 children)

 Exclusion Criteria:

 -  The subject has Hydrops fetalis

 -  The subject has major congenital malformations, diseases or skin conditions or
 thickness that, in the opinion of the investigator would preclude or interfere with
 the use of the JM-105