Ultrasound Assessment for Predicting Optimal Umbilical Venous Catheter Placement

February 19, 2026 updated by: Princess Anna Mazowiecka Hospital, Warsaw, Poland

Umbilical-Ductus Venosus Angle: A Novel Ultrasound Tool for Predicting Optimal Umbilical Venous Catheter Placement

The goal of this clinical trial is to learn if the ultrasound assessment of the angle formed between the terminal segment of the Umbilical Venous and the initial segment of the Ductus Venosus (DV)play a role in Umbilical Venous Catheterization (UVC). The main questions it aims to answer are:

Can the Umbilical Venous-Ductus Venosus angle on Point-of-care ultrasonography improve the prediction and success of UVC placement in neonates ? The secondary aim was to assess the effectiveness of ultrasound-guided navigation with corrective maneuvers for correct UVC placement.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Umbilical venous catheterization are used in infants who are critically ill to ensure reliable central access, allowing for the administration of parenteral nutrition and medications. Catheterization of the umbilical vein involves numerous potential complications. A large proportion of these complications results from incorrect catheter positioning. Catheter tip may be malpositioned, with reported failure rates of up to 50%, which may be associated with an increased risk of complications. Thoracoabdominal radiography (TAR) has long been the standard approach for confirming catheter tip position. Clinical studies have consistently demonstrated discrepancies between radiologic and ultrasonographic evaluations in determining central catheter tip position.

Point-of-care ultrasonography enables efficient vascular access and reliable assessment of catheter tip position. What more, we hope this approach aids in selecting appropriate corrective maneuvers, may reduce the number of insertion attempts.

The primary aim of the ultrasonographic assessment of umbilical venous catheter positioning was to evaluate the anatomical course of the umbilical venous and the ductus venosus, as well as their influence on the correct placement of the catheter within the umbilical vein.

The secondary objective was to evaluate the effectiveness of ultrasound-guided navigation combined with corrective maneuvers in achieving the correct placement of the UVC.

Study Type

Observational

Enrollment (Actual)

78

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Rzeszów, Poland, 35-055
        • Department of Neonatology with Neonatal Intensive Care Unit, University Clinical Hospital in Rzeszów, Chopina 2
      • Warsaw, Poland, 00-315
        • Department of Neonatology and Neonatal Intensive Care Medical University of Warsaw, Karowa 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This observational, prospective, single-center, population-based cohort study was conducted at the Neonatal and Intensive Care Department of the University Frederic Chopin Hospital of Rzeszów (Poland). Neonates born at ≥24 weeks' gestation who required parenteral nutrition in the early postnatal period were eligible for inclusion in the study and underwent umbilical venous catheter placement.

Description

Inclusion Criteria:

Neonates born at at ≥24 weeks of gestational age who required parenteral nutrition during the early postnatal period.

Exclusion Criteria:

Individuals with congenital gastrointestinal tract malformations, agenesis of the ductus venosus, or those delivered prior to 24 weeks of gestation were excluded from the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
All participants who met the inclusion criteria were divided into two groups.

Group 1 (low catheter position) included participants in whom the catheter tip was located in an inappropriate position within the portal venous circulation.

Group 2 (high catheter position) included participants in whom the catheter tip was positioned above the ductus venosus within the inferior vena cava.
Diagnostic test: Ultrasound assessment of UV-DV angle
Ultrasound measurement of the umbilical vein-ductus venosus (UV-DV) angle in neonates undergoing umbilical venous catheter placement, with assessment according to catheter tip position.
Diagnostic test: Ultrasound-guided corrective maneuvers for UVC placement
Real-time ultrasound-guided corrective maneuvers were performed to reposition umbilical venous catheters initially located in a low position, with advancement of the catheter toward the correct anatomical location.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Umbilical Venous-Ductus Venosus Angle
Time Frame: within the first 72 hours of life
The obtuse angle (measured in degrees) between the terminal segment of the umbilical vein and the initial segment of the ductus venosus, assessed using point-of-care ultrasound.
within the first 72 hours of life

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of the umbilical venous-ductus venosus angle between low and high umbilical venous catheter positioning
Time Frame: within the first 72 hours of life
The umbilical vein-ductus venosus (UV-DV) angle measured by point-of-care ultrasound was compared between neonates with low-positioned and high-positioned umbilical venous catheters.
within the first 72 hours of life
Success Rate of Ultrasound-Guided Maneuvers
Time Frame: within the first 72 hours of life
Proportion of participants with initially malpositioned umbilical venous catheters in whom correct catheter position is achieved after ultrasound-guided maneuvers
within the first 72 hours of life
Causes of Umbilical Venous Catheter Malposition
Time Frame: within the first 72 hours of life
Frequency and type of identified causes of catheter malposition detected during ultrasound assessment
within the first 72 hours of life

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Princess Anna Mazowiecka Hospital, Warsaw, Poland

Investigators

  • Principal Investigator: Kamil Gierek, M.D., Department of Neonatology with Neonatal Intensive Care Unit, University Clinical Hospital in Rzeszów, Chopina 2, 35-055 Rzeszów, Poland
  • Study Chair: Renata Bokiniec, Prof. M.D., Department of Neonatology and Neonatal Intensive Care Medical University of Warsaw, Karowa 2

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 22, 2021

Primary Completion (Actual)

January 23, 2023

Study Completion (Actual)

January 23, 2023

Study Registration Dates

First Submitted

February 10, 2026

First Submitted That Met QC Criteria

February 19, 2026

First Posted (Actual)

February 25, 2026

Study Record Updates

Last Update Posted (Actual)

February 25, 2026

Last Update Submitted That Met QC Criteria

February 19, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Umbilical Venous Catheter

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Anatomy of the Ductus Venosus

Clinical Trials on Ultrasound assessment of UV-DV angle

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Armenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe