Transcutaneous Bilirubinometry and Phototherapy (TRABIN)

July 31, 2024 updated by: Jolita Bekhof, Princess Amalia Children's Clinic

Transcutaneous Bilirubinometry in Neonatal Hyperbilirubinemia During and After Phototherapy: a Randomized Controlled Trial

A randomized Controlled trial comparing the use of transcutaneous bilirubinometry to serum bilirubin measurements (via blooddraws = standard care) in neonates born after a gestational age > 32 weeks and < 15 days of age treated with Phototherapy for neonatal hyperbilrubinemia.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

A randomized Controlled trial comparing the use of transcutaneous bilirubinometry to serum bilirubin measurements (via blooddraws = standard care) in neonates born after a gestational age > 32 weeks and < 15 days of age treated with Phototherapy for neonatal hyperbilrubinemia. Main outcome measurement is the number of blooddraws for measurement of bilirubin. Secondary outcome measurements are duration of phototherapy and hospitalisation.

Study Type

Interventional

Enrollment (Estimated)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Netherlands
    • Overijssel
      • Zwolle, Overijssel, Netherlands, 8000 GK
        • Isala Klinieken

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 2 weeks (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Neonates with indication for phototherapy for treatment of hyperbilirubinemia

Exclusion Criteria:

  • skinlesions located on the sternum interfering with transcutaneous measurement
  • exchange transfusion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: transcutaneous bilirubinometry
in this arm the bilirubin level to monitor the effect of phototherapy will be measured through transcutaneous mbiirubinometry
Diagnostic test: Transcutaneous bilirubinometry
use of transcutaneous bilirubinometry a non-invasieve measurement of skin bilirubin levels
Active Comparator: serum bilirubin
In this arm the bilirubin level to monitor the effect of phototherapy wil be measured through measurements of serum bilirubin obtained through blood draws
Diagnostic test: Serum bilirubin
use of blood draws to measure serum bilirubin level
Other Names:
  • blood draw

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
blood draws
Time Frame: during hospitalisation with a maximum of 14 days
number of blood draws from the start of phototherapy for measurement of serum bilirubin
during hospitalisation with a maximum of 14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
phototherapy duration
Time Frame: during hospitalisation with a maximum of 14 days
duration of phototherapy in hours
during hospitalisation with a maximum of 14 days
hospitalisation
Time Frame: 3 months
duration of hospitalisation in days
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Princess Amalia Children's Clinic

Investigators

  • Principal Investigator: Jolita Bekhof, MD,PhD, 1971

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

January 26, 2020

First Submitted That Met QC Criteria

January 26, 2020

First Posted (Actual)

January 29, 2020

Study Record Updates

Last Update Posted (Actual)

August 2, 2024

Last Update Submitted That Met QC Criteria

July 31, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

After publishing the results the individual participant data will be anonimously available upon request

IPD Sharing Time Frame

after publication in a peer reviewed journal during 3 years

IPD Sharing Access Criteria

relevant research question

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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