Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-01 @ 2:18 AM
Study NCT ID:
NCT07434102
Status:
COMPLETED
Last Update Posted:
2026-02-25
First Post:
2026-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound Assessment for Predicting Optimal Umbilical Venous Catheter Placement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 78}, 'targetDuration': '10 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2023-01-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-19', 'studyFirstSubmitDate': '2026-02-10', 'studyFirstSubmitQcDate': '2026-02-19', 'lastUpdatePostDateStruct': {'date': '2026-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Umbilical Venous-Ductus Venosus Angle', 'timeFrame': 'within the first 72 hours of life', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Comparison of the umbilical venous-ductus venosus angle between low and high umbilical venous catheter positioning', 'timeFrame': 'within the first 72 hours of life', 'description': '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.'}, {'measure': 'Success Rate of Ultrasound-Guided Maneuvers', 'timeFrame': 'within the first 72 hours of life', 'description': 'Proportion of participants with initially malpositioned umbilical venous catheters in whom correct catheter position is achieved after ultrasound-guided maneuvers'}, {'measure': 'Causes of Umbilical Venous Catheter Malposition', 'timeFrame': 'within the first 72 hours of life', 'description': 'Frequency and type of identified causes of catheter malposition detected during ultrasound assessment'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ductus venosus', 'umbilical venous catheter positioning', 'umbilical vein-ductus venosus angle', 'ultrasound assessment'], 'conditions': ['Anatomy of the Ductus Venosus', 'Umbilical Venous Catheterization']}, 'referencesModule': {'references': [{'pmid': '3728405', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '5906629', 'type': 'BACKGROUND', 'citation': 'Dunn 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.'}, {'pmid': '37658020', 'type': 'BACKGROUND', 'citation': 'Torres 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.'}, {'pmid': '28424358', 'type': 'BACKGROUND', 'citation': 'Franta 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.'}, {'pmid': '33605663', 'type': 'BACKGROUND', 'citation': 'Moltu 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.'}, {'pmid': '35174113', 'type': 'BACKGROUND', 'citation': "D'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."}], 'seeAlsoLinks': [{'url': 'https://clinicaltrials.gov', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': '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:\n\nCan 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.', 'detailedDescription': '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.\n\nPoint-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.\n\nThe 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.\n\nThe secondary objective was to evaluate the effectiveness of ultrasound-guided navigation combined with corrective maneuvers in achieving the correct placement of the UVC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Days', 'minimumAge': '1 Day', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "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.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nNeonates born at at ≥24 weeks of gestational age who required parenteral nutrition during the early postnatal period.\n\nExclusion Criteria:\n\nIndividuals with congenital gastrointestinal tract malformations, agenesis of the ductus venosus, or those delivered prior to 24 weeks of gestation were excluded from the study.'}, 'identificationModule': {'nctId': 'NCT07434102', 'briefTitle': 'Ultrasound Assessment for Predicting Optimal Umbilical Venous Catheter Placement', 'organization': {'class': 'OTHER', 'fullName': 'Princess Anna Mazowiecka Hospital, Warsaw, Poland'}, 'officialTitle': 'Umbilical-Ductus Venosus Angle: A Novel Ultrasound Tool for Predicting Optimal Umbilical Venous Catheter Placement', 'orgStudyIdInfo': {'id': 'Umbilical Venous Catheter'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'All participants who met the inclusion criteria were divided into two groups.', 'description': 'Group 1 (low catheter position) included participants in whom the catheter tip was located in an inappropriate position within the portal venous circulation.\n\nGroup 2 (high catheter position) included participants in whom the catheter tip was positioned above the ductus venosus within the inferior vena cava.', 'interventionNames': ['Diagnostic Test: Ultrasound assessment of UV-DV angle', 'Diagnostic Test: Ultrasound-guided corrective maneuvers for UVC placement']}], 'interventions': [{'name': 'Ultrasound assessment of UV-DV angle', 'type': 'DIAGNOSTIC_TEST', 'description': '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.', 'armGroupLabels': ['All participants who met the inclusion criteria were divided into two groups.']}, {'name': 'Ultrasound-guided corrective maneuvers for UVC placement', 'type': 'DIAGNOSTIC_TEST', 'description': '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.', 'armGroupLabels': ['All participants who met the inclusion criteria were divided into two groups.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35-055', 'city': 'Rzeszów', 'country': 'Poland', 'facility': 'Department of Neonatology with Neonatal Intensive Care Unit, University Clinical Hospital in Rzeszów, Chopina 2', 'geoPoint': {'lat': 50.04132, 'lon': 21.99901}}, {'zip': '00-315', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Department of Neonatology and Neonatal Intensive Care Medical University of Warsaw, Karowa 2', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'overallOfficials': [{'name': 'Kamil Gierek, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Neonatology with Neonatal Intensive Care Unit, University Clinical Hospital in Rzeszów, Chopina 2, 35-055 Rzeszów, Poland'}, {'name': 'Renata Bokiniec, Prof. M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Neonatology and Neonatal Intensive Care Medical University of Warsaw, Karowa 2'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Princess Anna Mazowiecka Hospital, Warsaw, Poland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}