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NCT Number: NCT04246229

Transcutaneous Bilirubinometry and Phototherapy

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.

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Key information

Conditions

Neonatal Hyperbilirubinemia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hyperbilirubinemia Hyperbilirubinemia, Neonatal Infant, Newborn, Diseases Jaundice, Neonatal Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

0 day–2 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Isala Klinieken

Zwolle, Overijssel, 8000 GK, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Neonates with indication for phototherapy for treatment of hyperbilirubinemia

Exclusion criteria

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

Treatment and study plan

Transcutaneous bilirubinometry

Diagnostic Test

use of transcutaneous bilirubinometry a non-invasieve measurement of skin bilirubin levels

Serum bilirubin

Diagnostic Test

use of blood draws to measure serum bilirubin level

Other names: blood draw

Primary outcomes

  1. blood draws

    Time frame: during hospitalisation with a maximum of 14 days

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

Secondary outcomes

  1. phototherapy duration

    Time frame: during hospitalisation with a maximum of 14 days

    duration of phototherapy in hours

  2. hospitalisation

    Time frame: 3 months

    duration of hospitalisation in days

Study contacts

Contact information is provided by the study sponsor or research team.

Jolita Bekhof, MD, PhD

CONTACT

[email protected]

+31384245050

Sponsors and collaborators

Lead sponsor

Princess Amalia Children's Clinic

Other

Registry information

Official study title

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

Acronym: TRABIN

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jan 29, 2020
Registry last updated
Aug 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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