Neonatal Jaundice Clinical Trial
Official title:
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
NCT number | NCT02774434 |
Other study ID # | JM-105 Study |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 2016 |
Est. completion date | June 2018 |
Verified date | February 2019 |
Source | Draeger Medical Systems, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 464 |
Est. completion date | June 2018 |
Est. primary completion date | June 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 24 Weeks to 40 Weeks |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Canada | Hamilton Health Science Centre | Toronto | Ontario |
Canada | Mount Sinai Hospital | Toronto | Ontario |
Canada | Saint Michael's Hospital | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Draeger Medical Systems, Inc. |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | Influence of phototherapy on TSB measurements | The Impact of phototherapy on TSB measurements will be explored. | Within 15 minutes of blood sample taking |
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