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Validity of Transcutaneous Bilirubin Monitoring in Preterm Infants

NCT03195998 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 166

Last updated 2025-06-03

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Banner University Medical Center

    collaborator OTHER

  • Pediatrix

    lead OTHER

Principal Investigators

  • Suma Rao, MD · Pediatrix

Eligibility

Min Age
23 Weeks
Max Age
34 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-30
Primary Completion
2019-02-01
Completion
2019-02-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03195998 on ClinicalTrials.gov