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Transcutaneous Bilirubinometry and Phototherapy (TRABIN)

Primary Purpose

Neonatal Hyperbilirubinemia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Transcutaneous bilirubinometry
Serum bilirubin
Sponsored by
Princess Amalia Children's Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Neonatal Hyperbilirubinemia focused on measuring transcutaneous bilirubinometry, phototherapy, neonatal icterus, neonatal jaundice, newborn

Eligibility Criteria

0 Days - 2 Weeks (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Neonates with indication for phototherapy for treatment of hyperbilirubinemia

Exclusion Criteria:

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

Sites / Locations

  • Isala Klinieken

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

transcutaneous bilirubinometry

serum bilirubin

Arm Description

in this arm the bilirubin level to monitor the effect of phototherapy will be measured through transcutaneous mbiirubinometry

In this arm the bilirubin level to monitor the effect of phototherapy wil be measured through measurements of serum bilirubin obtained through blood draws

Outcomes

Primary Outcome Measures

blood draws
number of blood draws from the start of phototherapy for measurement of serum bilirubin

Secondary Outcome Measures

phototherapy duration
duration of phototherapy in hours
hospitalisation
duration of hospitalisation in days

Full Information

First Posted
January 26, 2020
Last Updated
March 29, 2023
Sponsor
Princess Amalia Children's Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT04246229
Brief Title
Transcutaneous Bilirubinometry and Phototherapy
Acronym
TRABIN
Official Title
Transcutaneous Bilirubinometry in Neonatal Hyperbilirubinemia During and After Phototherapy: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2024 (Anticipated)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
May 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Princess Amalia Children's Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Hyperbilirubinemia
Keywords
transcutaneous bilirubinometry, phototherapy, neonatal icterus, neonatal jaundice, newborn

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
transcutaneous bilirubinometry
Arm Type
Experimental
Arm Description
in this arm the bilirubin level to monitor the effect of phototherapy will be measured through transcutaneous mbiirubinometry
Arm Title
serum bilirubin
Arm Type
Active Comparator
Arm Description
In this arm the bilirubin level to monitor the effect of phototherapy wil be measured through measurements of serum bilirubin obtained through blood draws
Intervention Type
Diagnostic Test
Intervention Name(s)
Transcutaneous bilirubinometry
Intervention Description
use of transcutaneous bilirubinometry a non-invasieve measurement of skin bilirubin levels
Intervention Type
Diagnostic Test
Intervention Name(s)
Serum bilirubin
Other Intervention Name(s)
blood draw
Intervention Description
use of blood draws to measure serum bilirubin level
Primary Outcome Measure Information:
Title
blood draws
Description
number of blood draws from the start of phototherapy for measurement of serum bilirubin
Time Frame
during hospitalisation with a maximum of 14 days
Secondary Outcome Measure Information:
Title
phototherapy duration
Description
duration of phototherapy in hours
Time Frame
during hospitalisation with a maximum of 14 days
Title
hospitalisation
Description
duration of hospitalisation in days
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Days
Maximum Age & Unit of Time
2 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Neonates with indication for phototherapy for treatment of hyperbilirubinemia Exclusion Criteria: skinlesions located on the sternum interfering with transcutaneous measurement exchange transfusion
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jolita Bekhof, MD, PhD
Phone
+31384245050
Email
j.bekhof@isala.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jolita Bekhof, MD,PhD
Organizational Affiliation
1971
Official's Role
Principal Investigator
Facility Information:
Facility Name
Isala Klinieken
City
Zwolle
State/Province
Overijssel
ZIP/Postal Code
8000 GK
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

Transcutaneous Bilirubinometry and Phototherapy

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