Transcutaneous Bilirubinometry and Phototherapy

Not Applicable

Not yet recruiting

• Conditions: Neonatal Hyperbilirubinemia
• Interventions: Diagnostic Test: Serum bilirubin; Diagnostic Test: Transcutaneous bilirubinometry

• Registration Number: NCT04246229
• Lead Sponsor: Princess Amalia Children's Clinic

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.

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 Timeline

• Study First Submitted: 2020-01-26
• Study First Submitted QC: 2020-01-26
• Study First Posted: 2020-01-29
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-31
• Last Update Posted: 2024-08-02
• Study Start: 2026-01-01
• Primary Completion: 2026-12-31
• Study Completion: 2027-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 130

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
serum bilirubin	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
transcutaneous bilirubinometry	Transcutaneous bilirubinometry	in this arm the bilirubin level to monitor the effect of phototherapy will be measured through transcutaneous mbiirubinometry

Primary Outcome Measures

Name	Time	Method
blood draws	during hospitalisation with a maximum of 14 days	number of blood draws from the start of phototherapy for measurement of serum bilirubin

Secondary Outcome Measures

Name	Time	Method
hospitalisation	3 months	duration of hospitalisation in days
phototherapy duration	during hospitalisation with a maximum of 14 days	duration of phototherapy in hours

Trial Locations

Locations (1)

Isala Klinieken; 🇳🇱 Zwolle, Overijssel, Netherlands