Efficacy Study of the Draeger Jaundice Meter (JM-105) in Neonates of ≥ 24 Weeks of Gestational Age

NCT02774434 | Completed

• 1 other identifier: JM-105 Study
• Study Type: interventional
• Target: 464
• Locations: 1 country
• Sites: 3

Brief 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).

Conditions

Hyperbilirubinemia; Neonatal Jaundice

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Normalized curve of TSB measurements using the JM-105

  Within 15 minutes of blood sample taking

• Influence of phototherapy on TSB measurements

  Within 15 minutes of blood sample taking

Study Arms (1)

JM-105

EXPERIMENTAL

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

Interventions

JM-105 DEVICE

Measurement of TcB via the JM-105 device

JM-105

Eligibility Criteria

• Age: 24 Weeks - 40 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Draeger Medical Systems, Inc.: lead

Study Sites (3)

Saint Michael's Hospital

Toronto, Ontario, M5B1W8, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

Hamilton Health Science Centre

Toronto, Ontario, Canada

Location

Related Publications (1)

• 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.

  PMID: 34139689 DERIVED

MeSH Terms

Conditions

Hyperbilirubinemia; Jaundice, Neonatal

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hyperbilirubinemia, Neonatal; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Michael Sgro, MD

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2016
• First Posted: May 17, 2016
• Study Start: November 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: February 7, 2019

Record last verified: 2019-02

Locations

CA (3)