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 Providing TcB Measurements to Estimate TSB in Neonates of ≥ 24 Weeks of Gestational Age Who Have and Have Not Undergone Phototherapy

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).

Study Overview

• Status: Completed
• Conditions: Hyperbilirubinemia; Neonatal Jaundice
• Intervention / Treatment: Device: JM-105

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.

• Study Type: Interventional
• Enrollment (Actual): 464
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X5
      • Mount Sinai Hospital
    • Toronto, Ontario, Canada, M5B1W8
      • Saint Michael's Hospital
    • Toronto, Ontario, Canada
      • Hamilton Health Science Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: JM-105; 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.	Device: JM-105; Measurement of TcB via the JM-105 device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of TcB measured with the JM-105 device in predicting the Serum Bilirubin measurements performed on blood samples	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	Within 15 minutes of blood sample taking

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Normalized curve of TSB measurements using the JM-105	The secondary objective is to determine a normalized curve of TSB measurements using the JM-105.	Within 15 minutes of blood sample taking
Influence of phototherapy on TSB measurements	The Impact of phototherapy on TSB measurements will be explored.	Within 15 minutes of blood sample taking

Collaborators and Investigators

• Sponsor: Draeger Medical Systems, Inc.
• Investigators: Principal Investigator: Michael Sgro, MD, Unity Health Toronto

Publications and helpful links

General Publications

• Jegathesan T, Campbell DM, Ray JG, Shah V, Berger H, Hayeems RZ, Sgro M; NeoHBC. Transcutaneous versus Total Serum Bilirubin Measurements in Preterm Infants. Neonatology. 2021;118(4):443-453. doi: 10.1159/000516648. Epub 2021 Jun 17.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: May 6, 2016
• First Submitted That Met QC Criteria: May 13, 2016
• First Posted (Estimate): May 17, 2016

Study Record Updates

• Last Update Posted (Actual): February 7, 2019
• Last Update Submitted That Met QC Criteria: February 6, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infant, Newborn, Diseases; Skin Manifestations; Hyperbilirubinemia, Neonatal; Jaundice; Hyperbilirubinemia; Jaundice, Neonatal
• Other Study ID Numbers: JM-105 Study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No