Clinical trial NCT02774434: Efficacy Study of the Draeger Jaundice Meter (JM-105) in Neonates of ≥ 24 Weeks of Gestational Age
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperbilirubinemia
Neonatal Jaundice
Lead sponsor: Draeger Medical Systems, Inc.
Sponsor class: INDUSTRY
First posted: 2016-05-17
Enrollment: 464
Sex: ALL
Minimum age (years): 24
Maximum age (years): 40
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Accuracy of TcB measured with the JM-105 device in predicting the Serum Bilirubin measurements performed on blood samples
timeFrame: Within 15 minutes of blood sample taking
Secondary outcomes:
measure: Normalized curve of TSB measurements using the JM-105
timeFrame: Within 15 minutes of blood sample taking
measure: Influence of phototherapy on TSB measurements
timeFrame: Within 15 minutes of blood sample taking
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Saint Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: Toronto
country: Canada
facility: Hamilton Health Science Centre
state: Ontario
Study officials:
affiliation: Unity Health Toronto
name: Michael Sgro, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.