Neonatal Umbilical Catheter Pathway Simulator
Phase: NA
Conditions: Simulator Training, Neonates and Preterm Infants, Catherization
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

 
Protocol_ NeoPath _V.1.0 del 20/11/2024       
 
                       Pag. 1 | 6 
Neonatal Umbilical Catheter Pathway Simulator 
 
Principal Investigator: Dr. Vito D’Andrea 
 
Sub-investigators: Dr. Giorgia Prontera 
Contributor: Eng. Federica Cinti 
 
Sponsor: Fondazione Policlinico Universitario A. Gemelli IRCCS 
 
Founding: None 
 
Versione: 1.0 
 
Date: 20/11/2024

 
Protocol_ NeoPath _V.1.0 del 20/11/2024       
 
                       Pag. 2 | 6 
 
Study Background and Rationale 
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. 
Study Objectives 
Primary Objective 
To design and construct a realistic educational simulator for the placement of umbilical venous 
catheters in neonates. 
Secondary Objectives 
1. To assess the simulator’s durability after 100 hours of training use. 
2. To collect expert feedback on the simulator’s realism and ease of use. 
3. To evaluate the reliability and safety of the simulator after extended use, verifying 
structural resistance and suitability for training purposes. 
4. To assess whether the use of the simulator leads to increase in vivo use of ultrasound 
during actual umbilical catheter insertions. 
Study Endpoints 

 
Protocol_ NeoPath _V.1.0 del 20/11/2024       
 
                       Pag. 3 | 6 
Primary Endpoint 
Assessment of simulator usability and practicality, measured via user satisfaction questionnaires. 
Secondary Endpoints 
• 
Accuracy of the simulator in reproducing neonatal hepatic venous anatomy. 
• 
Improvement in participants’ practical skills, assessed via pre- and post-training tests. 
• 
Evaluation of simulator durability and safety under training conditions. 
Study Design 
This is an interventional, non-drug, non-device study focused on procedural simulation. It aims 
to develop and validate a training tool to enhance clinical competencies in neonatal 
catheterization. 
Participants 
A total of 25 individuals will participate: 
• 
5 experienced neonatal ultrasound practitioners, who will test and validate the 
simulator. 
• 
20 less-experienced healthcare professionals or medical trainees, who will participate in 
the training sessions. 
• 
1 neonatal patient whose abdominal CT scan will be used (with parental consent) for 
vascular 3D reconstruction purposes. 
Inclusion Criteria 

 
Protocol_ NeoPath _V.1.0 del 20/11/2024       
 
                       Pag. 4 | 6 
• 
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. 
• 
Written informed consent is required from all participants and from the legal guardians 
of the neonate providing imaging data. 
Exclusion Criteria 
• 
Less than 3 years of relevant experience for expert participants. 
• 
Less than 3rd year of specialty training for trainee participants. 
Study Duration 
The entire study will be conducted over 12 months. 
Study Procedures 
1. Simulator Construction: A 3D ultrasound-compatible model of the umbilical and hepatic 
venous system will be created from an abdominal CT scan of a neonate obtained for 
clinical reasons. 
2. Expert Evaluation: Neonatal ultrasound experts will assess the anatomical and 
procedural realism of the simulator. 
3. Training Phase: Once validated, training sessions will be conducted with medical trainees 
to enhance their procedural skills and ultrasound competence. 
4. Satisfaction Assessment: A feedback questionnaire will be administered to all 
participants to assess user experience. 
Statistical Analysis 

 
Protocol_ NeoPath _V.1.0 del 20/11/2024       
 
                       Pag. 5 | 6 
Sample Size: 
25 participants (5 experts and 20 trainees) are planned for enrollment. 
Analysis Methods: 
• 
Demographic and baseline characteristics will be described using descriptive statistics. 
• 
Quantitative variables will be reported as medians and interquartile ranges. 
• 
Qualitative variables will be presented as absolute and relative frequencies. 
• 
User satisfaction will be evaluated through questionnaire analysis. 
• 
Skill improvement will be analyzed using the paired Student’s t-test or Wilcoxon test, with 
p-values < 0.05 considered statistically significant. 
Statistical analysis will be performed using R software (R, CRAN). 
Safety and Adverse Events 
No specific risks or adverse event monitoring procedures are defined, as the study involves 
simulation and not clinical interventions. 
 
References 
D'Andrea V, et al. Umbilical Venous Catheter Update: A Narrative Review Including Ultrasound 
and Training.» Frontiers in Pediatrics, 2021. 
 
Yeung, CY, et al. Complications of umbilical venous catheters in neonates: A safety reappraisal.» 
Pediatrics And Neonatology, 2020: 1-2. 

 
Protocol_ NeoPath _V.1.0 del 20/11/2024       
 
                       Pag. 6 | 6 
 
Sawyer T, et al. Real vs simulated umbilical cords for emergency umbilical catheterization 
training: a randomized crossover study. J Perinatol. (2017) 37:177–81. doi: 10.1038/jp.2016.194 
 
Haviland C, et al. Simulated umbilical venous catheter placement improves resident competence 
and conﬁdence. Cureus. (2020) 12:e10810. doi: 10.7759/cureus.10810 
 
Sawyer T, et al. A real human umbilical cord simulator model for emergency umbilical venous 
catheter placement training. Cureus. (2018) 10:e3544. doi: 10.7759/cureus.3544 
 
Meinen RD, et al. Point-of-care ultrasound use in umbilical line placement: a review. J Perinatol. 
(2020) 40:560–6. doi: 10.1038/s41372-019-0558-8 
 
R, Kyng KJ, et al. Learning curves for training in ultrasonography-based examination of umbilical 
catheter placement: a piglet study. Neonatology. (2020) 117:144–50. doi: 10.1159/000503176