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Completed No phase listed Observational

Validity of Transcutaneous Bilirubin Monitoring in Preterm Infants

ClinicalTrials.gov ID: NCT03195998

Public ClinicalTrials.gov record NCT03195998. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 30, 2026, 1:20 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Determining the Validity of Transcutaneous Bilirubin Monitoring in Preterm Infants With a Gestational Age of 23 0/7 - 34 6/7 Weeks

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT03195998
Recruitment status
Completed
Study type
Observational
Phase
Not listed
Lead sponsor
Pediatrix
Other
Enrollment
166 participants

Conditions and interventions

Interventions

Diagnostic Test

Eligibility (public fields only)

Age range
23 Weeks to 34 Weeks
Sex
All
Healthy volunteers
Not listed

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 30, 2017 (Actual)
Primary completion
Feb 1, 2019 (Actual)
Completion
Feb 1, 2019 (Actual)
Last update posted
Jun 3, 2025

2017 – 2019

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Banner - University Medical Center Phoenix Phoenix Arizona 85006 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03195998, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 3, 2025 · Synced Sep 30, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03195998 live on ClinicalTrials.gov.

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