Anatomy of the Ductus VenosusNCT07434102
Ultrasound Assessment for Predicting Optimal Umbilical Venous Catheter Placement
An observational study of Anatomy of the Ductus Venosus and Umbilical Venous Catheterization, run by Princess Anna Mazowiecka Hospital, Warsaw, Poland at 2 sites in Poland.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 1 day to 3 days
- Conditions the study is for
- Anatomy of the Ductus Venosus, Umbilical Venous Catheterization
- What is being tested?
- Ultrasound assessment of UV-DV angle and Ultrasound-guided corrective maneuvers for UVC placement
- How many people
- 78 participants
- Where
- 2 sitesPoland
- Study dates
- 22 Sep 2021to 23 Jan 2023
- How long will I take part?
- 10 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 3 days
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- Neonates born at at ≥24 weeks of gestational age who required parenteral nutrition during the early postnatal period.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Poland2 sites
Department of Neonatology with Neonatal Intensive Care Unit, University Clinical Hospital in Rzeszów, Chopina 2
Rzeszów, 35-055
Department of Neonatology and Neonatal Intensive Care Medical University of Warsaw, Karowa 2
Warsaw, 00-315
About this study
Official title: 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.
Read the 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.
- Being tested
- Ultrasound assessment of UV-DV angle, Ultrasound-guided corrective maneuvers for UVC placement
- Keywords
- ductus venosus, umbilical venous catheter positioning, umbilical vein-ductus venosus angle, ultrasound assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound assessment of UV-DV angleDiagnostic 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 placementDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Ultrasound assessment of UV-DV angle; Diagnostic Test: Ultrasound-guided corrective maneuvers for UVC placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Umbilical Venous-Ductus Venosus Angle
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.
Measured: within the first 72 hours of life
Secondary outcomes (3)
Comparison of the umbilical venous-ductus venosus angle between low and high umbilical venous catheter positioning
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.
Measured: within the first 72 hours of life
Success Rate of Ultrasound-Guided Maneuvers
Proportion of participants with initially malpositioned umbilical venous catheters in whom correct catheter position is achieved after ultrasound-guided maneuvers
Measured: within the first 72 hours of life
Causes of Umbilical Venous Catheter Malposition
Frequency and type of identified causes of catheter malposition detected during ultrasound assessment
Measured: within the first 72 hours of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start22 Sep 2021
- Primary completion23 Jan 2023
- Study completion23 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Anatomy of the Ductus VenosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 78 participants (actual)
- Target duration
- 10 Days
Sponsor and investigators
- Lead sponsor
- Princess Anna Mazowiecka Hospital, Warsaw, Poland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kamil Gierek, M.D., Principal investigator, Department of Neonatology with Neonatal Intensive Care Unit, University Clinical Hospital in Rzeszów, Chopina 2, 35-055 Rzeszów, PolandRenata Bokiniec, Prof. M.D., Study chair, Department of Neonatology and Neonatal Intensive Care Medical University of Warsaw, Karowa 2
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07434102
- Sponsor's protocol ID
- Umbilical Venous Catheter
- Status last verified
- Feb 2026
- First submitted
- 10 Feb 2026
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Shukla H, Ferrara A. Rapid estimation of insertional length of umbilical catheters in newborns. Am J Dis Child. 1986 Aug;140(8):786-8. doi: 10.1001/archpedi.1986.02140220068034.
PubMed 3728405Dunn PM. Localization of the umbilical catheter by post-mortem measurement. Arch Dis Child. 1966 Feb;41(215):69-75. doi: 10.1136/adc.41.215.69. No abstract available.
PubMed 5906629Torres Del Pino M, Gomez Santos E, Dominguez Quintero ML, Mendoza Murillo B, Millan Zamorano JA, Toledo Munoz-Cobo G, Mora Navarrocor D. Steps to improve umbilical vein catheterization in neonatal care. An Pediatr (Engl Ed). 2023 Sep;99(3):155-161. doi: 10.1016/j.anpede.2023.08.006. Epub 2023 Aug 30.
PubMed 37658020Franta J, Harabor A, Soraisham AS. Ultrasound assessment of umbilical venous catheter migration in preterm infants: a prospective study. Arch Dis Child Fetal Neonatal Ed. 2017 May;102(3):F251-F255. doi: 10.1136/archdischild-2016-311202. Epub 2016 Oct 18.
PubMed 28424358Moltu SJ, Bronsky J, Embleton N, Gerasimidis K, Indrio F, Koglmeier J, de Koning B, Lapillonne A, Norsa L, Verduci E, Domellof M; ESPGHAN Committee on Nutrition. Nutritional Management of the Critically Ill Neonate: A Position Paper of the ESPGHAN Committee on Nutrition. J Pediatr Gastroenterol Nutr. 2021 Aug 1;73(2):274-289. doi: 10.1097/MPG.0000000000003076.
PubMed 33605663D'Andrea V, Prontera G, Rubortone SA, Pezza L, Pinna G, Barone G, Pittiruti M, Vento G. Umbilical Venous Catheter Update: A Narrative Review Including Ultrasound and Training. Front Pediatr. 2022 Jan 31;9:774705. doi: 10.3389/fped.2021.774705. eCollection 2021.
PubMed 35174113Gierek K, Mikolajczak A, Stefanska M, Kusibab-Mytych M, Rozanska K, Bokiniec R. Umbilical vein-ductus venosus angle: a novel ultrasound marker for predicting optimal umbilical venous catheter placement. Eur J Pediatr. 2026 Jun 23;185(7):517. doi: 10.1007/s00431-026-07072-5.
PubMed 42334601
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Umbilical-Ductus Venosus Angle: A Novel Ultrasound Tool for Predicting Optimal Umbilical Venous Catheter Placement
- ClinicalTrials.gov ID
- NCT07434102
- Acronym / sponsor ID
- Umbilical Venous Catheter
- Keywords
- ductus venosus, umbilical venous catheter positioning, umbilical vein-ductus venosus angle, ultrasound assessment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Princess Anna Mazowiecka Hospital, Warsaw, PolandUniversity, hospital or other
- Study start
- 22 Sep 2021 (actual)
- Primary completion
- 23 Jan 2023 (actual)
- Study completion
- 23 Jan 2023 (actual)
- First posted
- 25 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants who met the inclusion criteria were divided into two groups. | – | Diagnostic Test: Ultrasound assessment of UV-DV angle, Diagnostic Test: Ultrasound-guided corrective maneuvers for UVC placementGroup 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. |
Who may qualify
- Ages
- 1 day to 3 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- Neonates born at at ≥24 weeks of gestational age who required parenteral nutrition during the early postnatal period.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound assessment of UV-DV angleUltrasound 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 | All participants who met the inclusion criteria were divided into two groups. |
| Ultrasound-guided corrective maneuvers for UVC placementReal-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. | Diagnostic test | All participants who met the inclusion criteria were divided into two groups. |
Primary outcome
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.
3 secondary outcomes
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
Success Rate of Ultrasound-Guided Maneuvers
Time frame: within the first 72 hours of life
Causes of Umbilical Venous Catheter Malposition
Time frame: within the first 72 hours of life
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Background: PubMed 3728405Shukla H, Ferrara A. Rapid estimation of insertional length of umbilical catheters in newborns. Am J Dis Child. 1986 Aug;140(8):786-8. doi: 10.1001/archpedi.1986.02140220068034.
- Background: PubMed 5906629Dunn PM. Localization of the umbilical catheter by post-mortem measurement. Arch Dis Child. 1966 Feb;41(215):69-75. doi: 10.1136/adc.41.215.69. No abstract available.
- Background: PubMed 37658020Torres Del Pino M, Gomez Santos E, Dominguez Quintero ML, Mendoza Murillo B, Millan Zamorano JA, Toledo Munoz-Cobo G, Mora Navarrocor D. Steps to improve umbilical vein catheterization in neonatal care. An Pediatr (Engl Ed). 2023 Sep;99(3):155-161. doi: 10.1016/j.anpede.2023.08.006. Epub 2023 Aug 30.
- Background: PubMed 28424358Franta J, Harabor A, Soraisham AS. Ultrasound assessment of umbilical venous catheter migration in preterm infants: a prospective study. Arch Dis Child Fetal Neonatal Ed. 2017 May;102(3):F251-F255. doi: 10.1136/archdischild-2016-311202. Epub 2016 Oct 18.
- Background: PubMed 33605663Moltu SJ, Bronsky J, Embleton N, Gerasimidis K, Indrio F, Koglmeier J, de Koning B, Lapillonne A, Norsa L, Verduci E, Domellof M; ESPGHAN Committee on Nutrition. Nutritional Management of the Critically Ill Neonate: A Position Paper of the ESPGHAN Committee on Nutrition. J Pediatr Gastroenterol Nutr. 2021 Aug 1;73(2):274-289. doi: 10.1097/MPG.0000000000003076.
- Background: PubMed 35174113D'Andrea V, Prontera G, Rubortone SA, Pezza L, Pinna G, Barone G, Pittiruti M, Vento G. Umbilical Venous Catheter Update: A Narrative Review Including Ultrasound and Training. Front Pediatr. 2022 Jan 31;9:774705. doi: 10.3389/fped.2021.774705. eCollection 2021.
- Derived from this study: PubMed 42334601Gierek K, Mikolajczak A, Stefanska M, Kusibab-Mytych M, Rozanska K, Bokiniec R. Umbilical vein-ductus venosus angle: a novel ultrasound marker for predicting optimal umbilical venous catheter placement. Eur J Pediatr. 2026 Jun 23;185(7):517. doi: 10.1007/s00431-026-07072-5.
- Related InfoLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kamil Gierek, M.D. principal investigator
Department of Neonatology with Neonatal Intensive Care Unit, University Clinical Hospital in Rzeszów, Chopina 2, 35-055 Rzeszów, Poland
Renata Bokiniec, Prof. M.D. study chair
Department of Neonatology and Neonatal Intensive Care Medical University of Warsaw, Karowa 2
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anatomy of the Ductus Venosus and Umbilical Venous Catheterization, run by Princess Anna Mazowiecka Hospital, Warsaw, Poland at 2 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Umbilical Venous-Ductus Venosus Angle (time frame: within the first 72 hours of life). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07434102, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026; AzTrials last refreshed its copy on 7 Nov 2026.