Efficacy Study of the Draeger Jaundice Meter (JM-105) in Neonates of ≥ 24 Weeks of Gestational Age
Condition: Hyperbilirubinemia; Neonatal Jaundice
MeSH terms: Jaundice, Neonatal; Jaundice; Hyperbilirubinemia
Study type: Interventional

Summary: 
      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).
    

Detailed description: 
      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.
    

Intervention name(s): JM-105
Intervention type(s): Device
Intervention description(s): Measurement of TcB via the JM-105 device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening