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

NCT02774434 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 464

Last updated 2019-02-07

No results posted yet for this study

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

Interventions

DEVICE

JM-105

Measurement of TcB via the JM-105 device

Sponsors & Collaborators

  • Draeger Medical Systems, Inc.

    lead INDUSTRY

Principal Investigators

  • Michael Sgro, MD · Unity Health Toronto

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
24 Weeks
Max Age
40 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2018-06-30
Completion
2018-06-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02774434 on ClinicalTrials.gov