Neonatal Umbilical Catheter Pathway Simulator
NeoPath
1 other identifier
interventional
25
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2025
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 27, 2025
CompletedStudy Start
First participant enrolled
August 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 5, 2025
CompletedFirst Posted
Study publicly available on registry
August 26, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2026
ExpectedAugust 26, 2025
August 1, 2025
4 days
July 27, 2025
August 22, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Neo Path
Evaluation of the simulator's practicality through a user satisfaction questionnaire.
12 months
Study Arms (1)
no-experienced neonatal ultrasound practitioners
EXPERIMENTALpratictioners who will test and validate the simulator.
Interventions
evaluate the quality of simulator
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Less than 3 years of relevant experience for expert participants. Less than 3rd year of specialty training for trainee participants.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (3)
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: 31758061RESULTKaae 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: 31661695RESULTD'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: 35174113RESULT
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Doctor
Study Record Dates
First Submitted
July 27, 2025
First Posted
August 26, 2025
Study Start
August 1, 2025
Primary Completion
August 5, 2025
Study Completion (Estimated)
July 30, 2026
Last Updated
August 26, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share