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NCT03195998 · ClinicalTrials.gov registry record
Validity of Transcutaneous Bilirubin Monitoring in Preterm Infants
A clinical trial, sponsored by Pediatrix.
- Completed
- Registry status
- 166
- Enrollment target
NCT03195998: Completed study, sponsored by Pediatrix.
NCT03195998 is a clinical trial that has completed, run by Pediatrix. The registered enrollment target is 166 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03195998 has completed, sponsored by Pediatrix.
- COMPLETED
- Registry status
- 166 participants
- Enrollment target
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.
Primary Outcome
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
Interventions
- DIAGNOSTIC_TEST TcB Measurement
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 166 participants |
| Start Date | 2017-06-30 |
| Est. Completion | 2019-02-01 |
What the finished NCT03195998 record still lists
NCT03195998 is an observational study that tracks outcomes without assigning an intervention. The registered 166 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which TcB Measurement is the first listed.
NCT03195998 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03195998 about?
NCT03195998 is a clinical study titled "Validity of Transcutaneous Bilirubin Monitoring in Preterm Infants". 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 additio...
What is the current status of trial NCT03195998?
This trial is currently completed. The enrollment target is 166 participants. The study started on 2017-06-30. Estimated completion is 2019-02-01.
What interventions are being tested in trial NCT03195998?
The interventions under investigation include: TcB Measurement (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03195998?
This trial is sponsored by Pediatrix, which has 28 total clinical trials registered on ClinicalTrials.gov.
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