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Not yet recruiting NCT07142434

Neonatal Umbilical Catheter Pathway Simulator

No phase Interventional Simulator Training Neonates and Preterm Infants Catherization

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: neonatal Umbilical Catheter Pathway Simulator.
Who it may be relevant to
Registry conditions: Simulator Training, Neonates and Preterm Infants, Catherization. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Device neonatal Umbilical Catheter Pathway Simulator
    evaluate the quality of simulator

Primary outcome measures

  • Neo Path [Time frame: 12 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Health services research

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • 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. PMID 31758061
  • 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. PMID 31661695
  • 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. PMID 35174113

Identifiers

NCT: NCT07142434 · 7348

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗