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
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
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
NCT ID
NCT04246229
First Posted
January 26, 2020
Last Updated
March 29, 2023
Sponsor
Princess Amalia Children's Clinic
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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