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NCT04246229 Clinical Trial

Transcutaneous Bilirubinometry and Phototherapy

Neonatal Hyperbilirubinemia Clinical Trial

— TRABIN  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04246229
Other study ID # 202001
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 1, 2024
Est. completion date May 1, 2027

Study information
Verified date March 2023
Source Princess Amalia Children's Clinic
Contact Jolita Bekhof, MD, PhD
Phone +31384245050
Email j.bekhof@isala.nl
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 130
Est. completion date May 1, 2027
Est. primary completion date December 31, 2026
Accepts healthy volunteers No
Gender All
Age group 0 Days to 2 Weeks
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Transcutaneous bilirubinometry
use of transcutaneous bilirubinometry a non-invasieve measurement of skin bilirubin levels
• Serum bilirubin
use of blood draws to measure serum bilirubin level

Locations
Country Name City State
Netherlands Isala Klinieken Zwolle Overijssel

Sponsors (1)
Lead Sponsor Collaborator
Princess Amalia Children's Clinic

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary blood draws number of blood draws from the start of phototherapy for measurement of serum bilirubin during hospitalisation with a maximum of 14 days
Secondary phototherapy duration duration of phototherapy in hours during hospitalisation with a maximum of 14 days
Secondary hospitalisation duration of hospitalisation in days 3 months
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