Transcutaneous Bilirubinometry and Phototherapy (TRABIN)

Princess Amalia Children's Clinic

Status: Not yet enrolling

Conditions: Neonatal Hyperbilirubinemia

Treatments: Diagnostic Test: Serum bilirubin; Diagnostic Test: Transcutaneous bilirubinometry

Study type: Interventional

Funder types: Other

Identifiers

NCT04246229

202001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 130 estimated patients

Sex: All

Ages: Under 2 weeks old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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130 participants in 2 patient groups

transcutaneous bilirubinometry

Experimental group

Description:

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

Treatment:

Diagnostic Test: Transcutaneous bilirubinometry

serum bilirubin

Active Comparator group

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

Treatment:

Diagnostic Test: Serum bilirubin