Transcutaneous Bilirubinometry and Phototherapy

NCT04246229 | Not Yet Recruiting DMC

• 1 other identifier: 202001
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonatal Hyperbilirubinemia

Keywords

transcutaneous bilirubinometry; phototherapy; neonatal icterus; neonatal jaundice; newborn

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• phototherapy duration

  during hospitalisation with a maximum of 14 days

• hospitalisation

  3 months

Study Arms (2)

transcutaneous bilirubinometry

EXPERIMENTAL

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

Diagnostic Test: Transcutaneous bilirubinometry

serum bilirubin

ACTIVE COMPARATOR

In this arm the bilirubin level to monitor the effect of phototherapy wil be measured through measurements of serum bilirubin obtained through blood draws

Diagnostic Test: Serum bilirubin

Interventions

Transcutaneous bilirubinometry DIAGNOSTIC_TEST

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

transcutaneous bilirubinometry

Serum bilirubin DIAGNOSTIC_TEST

use of blood draws to measure serum bilirubin level

Also known as: blood draw

serum bilirubin

Eligibility Criteria

• Age: 0 Days - 2 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Neonates with indication for phototherapy for treatment of hyperbilirubinemia

You may not qualify if:

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

Sponsors & Collaborators

• Princess Amalia Children's Clinic: lead

Study Sites (1)

Isala Klinieken

Zwolle, Overijssel, 8000 GK, Netherlands

Location

MeSH Terms

Conditions

Hyperbilirubinemia, Neonatal; Jaundice, Neonatal

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Jolita Bekhof, MD,PhD

  1971

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jolita Bekhof, MD, PhD

CONTACT

+31384245050; j.bekhof@isala.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD Principal Investigator

Study Record Dates

• First Submitted: January 26, 2020
• First Posted: January 29, 2020
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: August 2, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: after publication in a peer reviewed journal during 3 years
• Access Criteria: relevant research question

Locations

NL (1)