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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| no-experienced neonatal ultrasound practitioners | Experimental | pratictioners who will test and validate the simulator. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| neonatal Umbilical Catheter Pathway Simulator | Device | evaluate the quality of simulator |
|
| Measure | Description | Time Frame |
|---|---|---|
| Neo Path | Evaluation of the simulator's practicality through a user satisfaction questionnaire. | 12 months |
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Inclusion Criteria:
Trainees must be medical residents in their 3rd year or beyond.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vito D'Andrea | Contact | +393476334488 | dandrea.vito@gmail.com |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31758061 | Result | 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. | |
| 31661695 | Result | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 20, 2024 | Aug 16, 2025 | Prot_SAP_000.pdf |
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| 35174113 | Result | 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. |