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Trial record 8 of 2707 for:    bilirubin

Validity of Transcutaneous Bilirubin Monitoring in Preterm Infants (TcB)

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ClinicalTrials.gov Identifier: NCT03195998
Recruitment Status : Completed
First Posted : June 22, 2017
Last Update Posted : August 13, 2019
Sponsor:
Collaborator:
Banner University Medical Center
Information provided by (Responsible Party):
Mednax Center for Research, Education, Quality and Safety

Brief Summary:

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.


Condition or disease Intervention/treatment
Hyperbilirubinemia Diagnostic Test: TcB Measurement

Detailed Description:

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.


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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Determining the Validity of Transcutaneous Bilirubin Monitoring in Preterm Infants With a Gestational Age of 23 0/7 - 34 6/7 Weeks
Actual Study Start Date : June 30, 2017
Actual Primary Completion Date : February 1, 2019
Actual Study Completion Date : February 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Jaundice

Group/Cohort Intervention/treatment
Group A
Gestational Age 23 0/7 - 28 6/7 weeks
Diagnostic Test: TcB Measurement
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.

Group B
Gestational Age 29 0/7 weeks - 34 6/7 weeks
Diagnostic Test: TcB Measurement
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.




Primary Outcome Measures :
  1. validity of transcutaneous bilirubin measurements [ Time Frame: 2 years ]
    evaluate the validity of transcutaneous bilirubin measurements in premature infants born at 23 0/7- 28 6/7 weeks and 29 0/7 - 34 6/7 weeks gestation as compared to serum bilirubin measurements taken prior to, during and after phototherapy


Secondary Outcome Measures :
  1. treatment with phototherapy [ Time Frame: 2 years ]
    To compare transcutaneous bilirubin measurements obtained at different sites prior to and after treatment with phototherapy.

  2. cost savings [ Time Frame: 2 years ]
    To evaluate the cost savings of using the TcB meter measurements in place of the serum transcutaneous bilirubin



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Ages Eligible for Study:   23 Weeks to 34 Weeks   (Child)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Infants meeting gestational age criteria specified (23 0/7 up to 34 6/7 weeks gestation) without lethal congenital anomalies or hyperbilirubinemia requiring an exchange transfusion will be recruited for enrollment in this study. The enrolled babies will be divided into two groups based on gestational age as follows: Group A 23 0/7 - 28 6/7 weeks, and Group B 29 0/7 weeks - 34 6/7 weeks. A minimum of 60 infants will be enrolled into each group. As more subjects are likely to be eligible to be enrolled during the anticipated two year duration of the study, up to a maximum of 200 may be enrolled.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03195998


Locations
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United States, Arizona
Banner - University Medical Center Phoenix
Phoenix, Arizona, United States, 85006
Sponsors and Collaborators
Mednax Center for Research, Education, Quality and Safety
Banner University Medical Center
Investigators
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Principal Investigator: Suma Rao, MD Mednax Center for Research, Education, Quality and Safety

Publications:

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Responsible Party: Mednax Center for Research, Education, Quality and Safety
ClinicalTrials.gov Identifier: NCT03195998     History of Changes
Other Study ID Numbers: 16NE-GSAM-6364
First Posted: June 22, 2017    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Hyperbilirubinemia
Pathologic Processes
Bilirubin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs