Transcutaneous Bilirubinometry and Phototherapy

NCT ID: NCT04246229

Last Updated: 2024-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2027-05-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neonatal Hyperbilirubinemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

transcutaneous bilirubinometry

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

Group Type EXPERIMENTAL

Transcutaneous bilirubinometry

Intervention Type DIAGNOSTIC_TEST

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

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

Group Type ACTIVE_COMPARATOR

Serum bilirubin

Intervention Type DIAGNOSTIC_TEST

use of blood draws to measure serum bilirubin level

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Transcutaneous bilirubinometry

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

Intervention Type DIAGNOSTIC_TEST

Serum bilirubin

use of blood draws to measure serum bilirubin level

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

blood draw

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Neonates with indication for phototherapy for treatment of hyperbilirubinemia

Exclusion Criteria

* skinlesions located on the sternum interfering with transcutaneous measurement
* exchange transfusion
Minimum Eligible Age

0 Days

Maximum Eligible Age

2 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Princess Amalia Children's Clinic

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jolita Bekhof

MD PhD Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jolita Bekhof, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

1971

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Isala Klinieken

Zwolle, Overijssel, Netherlands

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Netherlands

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Jolita Bekhof, MD, PhD

Role: CONTACT

+31384245050

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

202001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Value of Transcutaneous Bilirubin Devices
NCT06232174 NOT_YET_RECRUITING
Cycled Phototherapy
NCT03927833 ACTIVE_NOT_RECRUITING NA
Hyperbilirubinemia in Full-term Neonates
NCT06238349 RECRUITING PHASE4