Validity of Transcutaneous Bilirubin Monitoring in Preterm Infants

NCT03195998 | Completed

• 1 other identifier: 16NE-GSAM-6364
• Study Type: observational
• Target: 166
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperbilirubinemia

Outcome Measures

Primary Outcomes (1)

• 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

  2 years

Secondary Outcomes (2)

• treatment with phototherapy

  2 years

• cost savings

  2 years

Study Arms (2)

Group A

Gestational Age 23 0/7 - 28 6/7 weeks

Diagnostic Test: TcB Measurement

Group B

Gestational Age 29 0/7 weeks - 34 6/7 weeks

Diagnostic Test: TcB Measurement

Interventions

TcB Measurement DIAGNOSTIC_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.

Group A; Group B

Eligibility Criteria

• Age: 23 Weeks - 34 Weeks
• Sex: all
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• Preterm neonates with gestational age at delivery of 23 0/7 to 34 6/7 weeks

You may not qualify if:

• 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

Sponsors & Collaborators

• Pediatrix: lead
• Banner University Medical Center: collaborator

Study Sites (1)

Banner - University Medical Center Phoenix

Phoenix, Arizona, 85006, United States

Location

Related Publications (9)

• 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.

  PMID: 24951079 BACKGROUND

• 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.

  PMID: 22624082 BACKGROUND

• 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.

  PMID: 25332501 BACKGROUND

• 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.

  PMID: 19909530 BACKGROUND

• 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.

  PMID: 19786452 BACKGROUND

• 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.

  PMID: 24127472 BACKGROUND

• 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.

  PMID: 24090969 BACKGROUND

• 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.

  PMID: 25601981 BACKGROUND

• 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.

  PMID: 19786443 BACKGROUND

MeSH Terms

Conditions

Hyperbilirubinemia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Suma Rao, MD

  Pediatrix

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2017
• First Posted: June 22, 2017
• Study Start: June 30, 2017
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: June 3, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)