Validity of Transcutaneous Bilirubin Monitoring in Preterm Infants
| Status: | Recruiting |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 8/18/2018 |
| Start Date: | June 30, 2017 |
| End Date: | February 1, 2019 |
| Contact: | Christine Wade, RN |
| Email: | christine_wade@mednax.com |
| Phone: | 602-703-9041 |
Determining the Validity of Transcutaneous Bilirubin Monitoring in Preterm Infants With a Gestational Age of 23 0/7 - 34 6/7 Weeks
The most common and widely accepted method of monitoring bilirubin levels in neonates is the
use of the laboratory analyzation of serum blood levels. Unfortunately this method is
invasive, painful, and can progressively lead to increased blood loss in the neonate. It also
requires the use of additional time and resources to coordinate sending the sample to the
laboratory and processing the specimen in the lab. There exists a different option for
obtaining bilirubin levels in neonates which is the transcutaneous bilirubinometer. This
device detects bilirubin levels at the bedside and has been validated for use in infants born
at > 35 weeks gestation. There are a limited number of studies evaluating its use in
premature infants.
Our aim is to assess the diagnostic accuracy and efficacy of transcutaneous bilirubinometry
(TcB) of the Dräger JM-103 by comparing (TcB) readings to total serum bilirubin (TSB) results
in neonates born at 23 0/7-34 6/7 weeks gestation.
use of the laboratory analyzation of serum blood levels. Unfortunately this method is
invasive, painful, and can progressively lead to increased blood loss in the neonate. It also
requires the use of additional time and resources to coordinate sending the sample to the
laboratory and processing the specimen in the lab. There exists a different option for
obtaining bilirubin levels in neonates which is the transcutaneous bilirubinometer. This
device detects bilirubin levels at the bedside and has been validated for use in infants born
at > 35 weeks gestation. There are a limited number of studies evaluating its use in
premature infants.
Our aim is to assess the diagnostic accuracy and efficacy of transcutaneous bilirubinometry
(TcB) of the Dräger JM-103 by comparing (TcB) readings to total serum bilirubin (TSB) results
in neonates born at 23 0/7-34 6/7 weeks gestation.
Design and Project Type In order to allow for appropriate data collection and comparison of
TSB versus TcB measurements, this will be a prospective cohort study design. The expected
duration will be 2 years. An interim analysis will occur approximately every six months.
Description of Intervention TcB measurements will be obtained within approximately 30 minutes
of the TSB being drawn before initiation of phototherapy, approximately 24 hours after the
initiation of phototherapy and approximately 24 hours after completion of phototherapy. The
TcB measurement will involve lightly pushing three times at each site which will yield an
average transcutaneous bilirubin value. This will be calculated for the interscapular,
buttock and sternal automatically by the bilirubinometer. While on phototherapy a measurement
of the diapered, non-exposed buttock area will be obtained at approximately 24 hours to
coincide with the standard of care serum bilirubin measurement.
Instruments The JM-103 is the bilirubinometer that will be utilized in obtaining TcB
measurements for this project. This meter is currently used on an as-needed basis within the
unit for late preterm or term infants.
Data Collection Basic demographic data such as gestational age, ethnicity and gender will be
collected. Relevant laboratory data such as blood type of mom and infant, and Coomb's test
results will be collected. In addition, enteral and intravenous nutrition data will be
collected including the type and volume of feeds at the same time the TcB is obtained. The
results, date, time and location of the TSB and TcB will be collected for analysis.
TcB measurements will be obtained on those infants that are already ordered to have a blood
draw for a serum bilirubin level. In the event the enrolled neonate does not require
phototherapy during their hospitalization, the initial baseline TSB and TcB measurements will
be collected and analyzed. Data will be collected during the first week of life. In the event
that a neonate requires a second course of phototherapy and this is initiated during the
first week of life, TcB and TSB measurements will be collected through the completion of
phototherapy at 24 hours post treatment. If the enrolled neonate does not require
phototherapy during their hospitalization, the initial baseline TSB and TcB measurements will
be collected and analyzed.
TSB versus TcB measurements, this will be a prospective cohort study design. The expected
duration will be 2 years. An interim analysis will occur approximately every six months.
Description of Intervention TcB measurements will be obtained within approximately 30 minutes
of the TSB being drawn before initiation of phototherapy, approximately 24 hours after the
initiation of phototherapy and approximately 24 hours after completion of phototherapy. The
TcB measurement will involve lightly pushing three times at each site which will yield an
average transcutaneous bilirubin value. This will be calculated for the interscapular,
buttock and sternal automatically by the bilirubinometer. While on phototherapy a measurement
of the diapered, non-exposed buttock area will be obtained at approximately 24 hours to
coincide with the standard of care serum bilirubin measurement.
Instruments The JM-103 is the bilirubinometer that will be utilized in obtaining TcB
measurements for this project. This meter is currently used on an as-needed basis within the
unit for late preterm or term infants.
Data Collection Basic demographic data such as gestational age, ethnicity and gender will be
collected. Relevant laboratory data such as blood type of mom and infant, and Coomb's test
results will be collected. In addition, enteral and intravenous nutrition data will be
collected including the type and volume of feeds at the same time the TcB is obtained. The
results, date, time and location of the TSB and TcB will be collected for analysis.
TcB measurements will be obtained on those infants that are already ordered to have a blood
draw for a serum bilirubin level. In the event the enrolled neonate does not require
phototherapy during their hospitalization, the initial baseline TSB and TcB measurements will
be collected and analyzed. Data will be collected during the first week of life. In the event
that a neonate requires a second course of phototherapy and this is initiated during the
first week of life, TcB and TSB measurements will be collected through the completion of
phototherapy at 24 hours post treatment. If the enrolled neonate does not require
phototherapy during their hospitalization, the initial baseline TSB and TcB measurements will
be collected and analyzed.
Inclusion Criteria:
- Preterm neonates with gestational age at delivery of 23 0/7 to 34 6/7 weeks
Exclusion Criteria:
- Neonates requiring blood exchange transfusion
- Lethal congenital anomalies
- Hydrops fetalis
- Infants who have received an intrauterine transfusion
- Investigator discretion as to other factors which might impact the study
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