HyperbilirubinemiaTcBNCT03195998
Validity of Transcutaneous Bilirubin Monitoring in Preterm Infants
An observational study of Hyperbilirubinemia, run by Pediatrix at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 23 to 34 weeks
- Conditions the study is for
- Hyperbilirubinemia
- What is being tested?
- TcB Measurement
- How many people
- 166 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2017to 1 Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 to 34 weeks
- All sexes
- Child
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.
Who may be able to join
- Preterm neonates with gestational age at delivery of 23 0/7 to 34 6/7 weeks
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Banner - University Medical Center Phoenix
Phoenix, Arizona, 85006
About this study
Official title: 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.
Read the 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.
- Conditions
- Hyperbilirubinemia
- Being tested
- TcB Measurement
- Medical subject headings
- Hyperbilirubinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TcB MeasurementDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Gestational Age 23 0/7 - 28 6/7 weeks Receives: Diagnostic Test: TcB Measurement | |
| Group B | Gestational Age 29 0/7 weeks - 34 6/7 weeks Receives: Diagnostic Test: TcB Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
validity of transcutaneous bilirubin measurements
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
Measured: 2 years
Secondary outcomes (2)
treatment with phototherapy
To compare transcutaneous bilirubin measurements obtained at different sites prior to and after treatment with phototherapy.
Measured: 2 years
cost savings
To evaluate the cost savings of using the TcB meter measurements in place of the serum transcutaneous bilirubin
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2017
- Study start30 Jun 2017
- Primary completion1 Feb 2019
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for HyperbilirubinemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pediatrix
- Sponsor type
- University, hospital or other
- Collaborators
- Banner University Medical Center
- Responsible party
- Sponsor
- Investigators
- Suma Rao, MD, Principal investigator, Pediatrix
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03195998
- Sponsor's protocol ID
- 16NE-GSAM-6364
- Acronym
- TcB
- Status last verified
- May 2025
- First submitted
- 20 Jun 2017
- Last updated
- 3 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24951079Badiee Z, Mohammadizadeh M, Shamee M. Diagnostic usefulness of transcutaneous bilirubinometry in very preterm newborns. Int J Prev Med. 2012 Apr;3(4):262-5.
PubMed 22624082Grabenhenrich 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.
PubMed 25332501Karen 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.
PubMed 19909530Maisels 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.
PubMed 19786452Nagar 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.
PubMed 24127472Rylance 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.
PubMed 24090969Taylor 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.
PubMed 25601981Varvarigou 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.
PubMed 19786443
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Validity of Transcutaneous Bilirubin Monitoring in Preterm Infants With a Gestational Age of 23 0/7 - 34 6/7 Weeks
- ClinicalTrials.gov ID
- NCT03195998
- Acronym / sponsor ID
- TcB / 16NE-GSAM-6364
- Conditions
- Hyperbilirubinemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- PediatrixUniversity, hospital or other
- Collaborators
- Banner University Medical Center
- Study start
- 30 Jun 2017 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 22 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Diagnostic Test: TcB MeasurementGestational Age 23 0/7 - 28 6/7 weeks |
| Group B | – | Diagnostic Test: TcB MeasurementGestational Age 29 0/7 weeks - 34 6/7 weeks |
Who may qualify
- Ages
- 23 to 34 weeks
- Sex
- All
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- Preterm neonates with gestational age at delivery of 23 0/7 to 34 6/7 weeks
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TcB MeasurementTcB 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. | Diagnostic test | Group A, Group B |
Primary outcome
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
2 secondary outcomes
treatment with phototherapy
Time frame: 2 years
cost savings
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
- Background: PubMed 24951079Afanetti 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.
- Background: PubMed 22624082Badiee Z, Mohammadizadeh M, Shamee M. Diagnostic usefulness of transcutaneous bilirubinometry in very preterm newborns. Int J Prev Med. 2012 Apr;3(4):262-5.
- Background: PubMed 25332501Grabenhenrich 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.
- Background: PubMed 19909530Karen 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.
- Background: PubMed 19786452Maisels 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.
- Background: PubMed 24127472Nagar 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.
- Background: PubMed 24090969Rylance 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.
- Background: PubMed 25601981Taylor 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.
- Background: PubMed 19786443Varvarigou 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suma Rao, MD principal investigator
Pediatrix
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperbilirubinemia, run by Pediatrix at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
validity of transcutaneous bilirubin measurements (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03195998, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2025.