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Completed

NCT Number: NCT07434102

Ultrasound Assessment 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.

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Key information

Age range

1 day–3 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Neonatology with Neonatal Intensive Care Unit, University Clinical Hospital in Rzeszów, Chopina 2, Rzeszów, Poland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Ultrasound assessment of UV-DV angle

Diagnostic Test

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.

Ultrasound-guided corrective maneuvers for UVC placement

Diagnostic Test

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Princess Anna Mazowiecka Hospital, Warsaw, Poland

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 25, 2026
Registry last updated
Feb 25, 2026

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

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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.