Neonatal Umbilical Catheter Pathway Simulator

NCT ID: NCT07142434

Last Updated: 2025-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-31

Study Completion Date

2026-07-30

Brief Summary

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Currently, training for umbilical catheter placement in neonates is primarily focused on inserting the catheter into the umbilical vein. However, no models to date allow real-time ultrasound assessment of catheter tip navigation and final positioning during the procedure. This study introduces the first training simulator designed specifically to address this need, enabling operators to practice not only the insertion but also the ultrasonographic localization of the catheter tip during the placement process.

Detailed Description

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Conditions

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Simulator Training Neonates and Preterm Infants Catherization

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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no-experienced neonatal ultrasound practitioners

pratictioners who will test and validate the simulator.

Group Type EXPERIMENTAL

neonatal Umbilical Catheter Pathway Simulator

Intervention Type DEVICE

evaluate the quality of simulator

Interventions

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neonatal Umbilical Catheter Pathway Simulator

evaluate the quality of simulator

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Experts must have at least 3 years of experience in neonatal abdominal ultrasound or central line placement.

Trainees must be medical residents in their 3rd year or beyond.

Exclusion Criteria

* Less than 3 years of relevant experience for expert participants. Less than 3rd year of specialty training for trainee participants.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role lead

Responsible Party

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D ANDREA VITO

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Vito D'Andrea

Role: CONTACT

+393476334488

References

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Meinen RD, Bauer AS, Devous K, Cowan E. Point-of-care ultrasound use in umbilical line placement: a review. J Perinatol. 2020 Apr;40(4):560-566. doi: 10.1038/s41372-019-0558-8. Epub 2019 Nov 22.

Reference Type RESULT
PMID: 31758061 (View on PubMed)

Kaae R, Kyng KJ, Frederiksen CA, Sloth E, Rosthoj S, Kerrn-Jespersen S, Eika B, Sorensen JL, Henriksen TB. Learning Curves for Training in Ultrasonography-Based Examination of Umbilical Catheter Placement: A Piglet Study. Neonatology. 2020;117(2):144-150. doi: 10.1159/000503176. Epub 2019 Oct 29.

Reference Type RESULT
PMID: 31661695 (View on PubMed)

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.

Reference Type RESULT
PMID: 35174113 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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7348

Identifier Type: -

Identifier Source: org_study_id

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