Validity of Transcutaneous Bilirubin Monitoring in Preterm Infants
NCT ID: NCT03195998
Last Updated: 2025-06-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
166 participants
OBSERVATIONAL
2017-06-30
2019-02-01
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Group A
Gestational Age 23 0/7 - 28 6/7 weeks
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
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Lethal congenital anomalies
* Hydrops fetalis
* Infants who have received an intrauterine transfusion
* Investigator discretion as to other factors which might impact the study
23 Weeks
34 Weeks
ALL
No
Sponsors
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Banner University Medical Center
OTHER
Pediatrix
OTHER
Responsible Party
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Principal Investigators
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Suma Rao, MD
Role: PRINCIPAL_INVESTIGATOR
Pediatrix
Locations
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Banner - University Medical Center Phoenix
Phoenix, Arizona, United States
Countries
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References
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Afanetti M, Eleni Dit Trolli S, Yousef N, Jrad I, Mokhtari M. Transcutaneous bilirubinometry is not influenced by term or skin color in neonates. Early Hum Dev. 2014 Aug;90(8):417-20. doi: 10.1016/j.earlhumdev.2014.05.009. Epub 2014 Jun 11.
Badiee Z, Mohammadizadeh M, Shamee M. Diagnostic usefulness of transcutaneous bilirubinometry in very preterm newborns. Int J Prev Med. 2012 Apr;3(4):262-5.
Grabenhenrich J, Grabenhenrich L, Buhrer C, Berns M. Transcutaneous bilirubin after phototherapy in term and preterm infants. Pediatrics. 2014 Nov;134(5):e1324-9. doi: 10.1542/peds.2014-1677. Epub 2014 Oct 20.
Karen T, Bucher HU, Fauchere JC. Comparison of a new transcutaneous bilirubinometer (Bilimed) with serum bilirubin measurements in preterm and full-term infants. BMC Pediatr. 2009 Nov 12;9:70. doi: 10.1186/1471-2431-9-70.
Maisels MJ, Bhutani VK, Bogen D, Newman TB, Stark AR, Watchko JF. Hyperbilirubinemia in the newborn infant > or =35 weeks' gestation: an update with clarifications. Pediatrics. 2009 Oct;124(4):1193-8. doi: 10.1542/peds.2009-0329. Epub 2009 Sep 28. No abstract available.
Nagar G, Vandermeer B, Campbell S, Kumar M. Reliability of transcutaneous bilirubin devices in preterm infants: a systematic review. Pediatrics. 2013 Nov;132(5):871-81. doi: 10.1542/peds.2013-1713. Epub 2013 Oct 14.
Rylance S, Yan J, Molyneux E. Can transcutaneous bilirubinometry safely guide phototherapy treatment of neonatal jaundice in Malawi? Paediatr Int Child Health. 2014 May;34(2):101-7. doi: 10.1179/2046905513Y.0000000050. Epub 2013 Dec 6.
Taylor JA, Burgos AE, Flaherman V, Chung EK, Simpson EA, Goyal NK, Von Kohorn I, Dhepyasuwan N; Better Outcomes through Research for Newborns Network. Discrepancies between transcutaneous and serum bilirubin measurements. Pediatrics. 2015 Feb;135(2):224-31. doi: 10.1542/peds.2014-1919. Epub 2015 Jan 19.
Varvarigou A, Fouzas S, Skylogianni E, Mantagou L, Bougioukou D, Mantagos S. Transcutaneous bilirubin nomogram for prediction of significant neonatal hyperbilirubinemia. Pediatrics. 2009 Oct;124(4):1052-9. doi: 10.1542/peds.2008-2322. Epub 2009 Sep 28.
Other Identifiers
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16NE-GSAM-6364
Identifier Type: -
Identifier Source: org_study_id
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