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Simulation-based Training on ResidentsSimuEchoNeoNCT06442683

Efficacy of Simulation-based Neonatal Echocardiography Training (SimuEchoNeo)

A study testing TTE simulation-based medical training in people with Simulation-based Training on Residents, run by University Hospital, Caen at 3 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Echocardiographic examination plays a critical role in neonatology, but its bedside training faces challenges due to limited patient access. While simulation training has proven effective in different fields of adult medical care, its application in neonatal echocardiography remains unexplored. Read more about this study

Who is it for?
Any age
Conditions the study is for
Simulation-based Training on Residents
What is being tested?
TTE simulation-based medical training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
3 sitesFrance
Study dates
2 May 2021to 31 Oct 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • residents at all training levels (from first to fifth year) completing a 6-month residency or at least night shifts in neonatology at one of the 3 French NICUs involved (University Hospitals of Caen, Rouen or Tours)

Who cannot join

  • Residents who had already received a TTE training (cardiology or cardiopediatrics 6-month residency or postgraduate training in cardiology or echocardiography)

Trial locations and contacts

3 sites in 1 country.

France3 sites
  • University Hospital of Caen

    Caen, France, 14000

  • University Hospital of Rouen

    Rouen, France, 76000

  • University Hospital of Tours

    Tours, France, Tours

Other trials in France

About this study

Official title: Efficacy of Simulation-based Neonatal Echocardiography Training: a Randomized Controlled Trial

Echocardiographic examination plays a critical role in neonatology, but its bedside training faces challenges due to limited patient access. While simulation training has proven effective in different fields of adult medical care, its application in neonatal echocardiography remains unexplored.

Researchers will compare simulation-based training to usual training (theorical and bedside) for neonatal echocardiography among pediatric residents to see if simulation-trained residents have better skills.

Participants will undergo :

  • theorial, simulation-based and bedside training or
  • theorical and bedside training only.
Read the detailed description

All participants were granted full access to the online theorical course throughout the semester of participation, which encompass a presentation of the study and a theorical training. In addition, during their Neonatal Intensive Care Unit (NICU) residency/night shifts, all residents had the possibility to learn bedside transthoracic echocardiography (TTE) and document their experiences using a collection form provided at the time of inclusion.

Beyond access to the e-learning, the simulation group participated in standardized training using the neonatal simulator EchoCom|Neo during the first month of their 6-month residency in NICU. The training session involved a maximum of four residents at the same time, one teacher and one EchoCom|Neo simulator.

The session consisted of the modified Peyton 4-steps process (demonstration, deconstruction, comprehension, performance) with the normal heart scenario set on the simulator, presentation of a persistent ductus arteriosus (PDA), a pericardial effusion case and an evaluation of each resident individually, on the simulator set with normal heart scenario, performing a TTE with a description of the visible structures. The minimum passing score for the validation of the training session was set at 12 out of 14 (reference score, table 1). If the minimum passing score was not achieved, a second training session must have been scheduled until the minimum passing score was reached.

The entire simulation session typically lasted between 2.5 to 3 hours. For standardization of training sessions, pre-registered videos were used whenever applicable (presentation of the simulation session, presentation of the simulator, and first and second Peyton's steps), and the training was conducted by the same teacher throughout the study, in the respective hospital of each resident (Caen, Rouen or Tours).

Two evaluation timepoints were defined at the middle (3 to 4 months after initial training, M3-M4), and at the end of the 6-month residency (6 months after the training, M6).

The evaluation session took place using the EchoCom|Neo simulator (EchoCom GmbH, Nieheim, Germany), set with the normal heart scenario, and placed on an open neonatal warmer, in the respective hospital of each resident. Each resident was evaluated individually with video recording for second evaluation.

Before starting the evaluation, each resident had 5 minutes to familiarize themselves with the handling of the simulator probe. They were asked to perform 7 TTE sections, with the teacher listing each expected TTE section at the beginning of the evaluation.

At each evaluation session, two evaluators conducted independent assessments. One evaluator was a pediatric cardiologist, blinded to the randomization, while the other was a pediatric resident (the simulation TTE training's teacher). One evaluator was physically present during the evaluation, while the other used video recording. Each evaluator assigned two scores for each resident:

  • A reference score: 2 points for each section (optimal, suboptimal, not found), total out of 14 points.
  • A custom-made score: 1 point for each anatomic structure within each section, emphasizing visualization and recognition of heart structures, total out of 33 points.

The duration of the TTE at 3 and 6 months were also recorded with second precision. Following the second evaluation at M6, the number of bedside TTE performed was documented, and a satisfaction questionnaire based on a Likert scale was requested.

Being tested
TTE simulation-based medical training
Keywords
Neonatology, Simulation-based training, Echocardiography

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TTE simulation-based medical trainingDiagnostic test

    half-day simulation-based neonatal echocardiography training.

Study groups in NCT06442683
Study groupRoleWhat they receive
Simulation groupExperimentalTheorical training, simulation-based training and bedside training
Receives: Diagnostic Test: TTE simulation-based medical training
Control groupNo interventionTheorical and bedside training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Transthoracic echocardiography (TTE) score at 3 months

    Difference in TTE score at 3 months between the two groups

    Measured: 3 to 4 months after initial training

Secondary outcomes (3)
  1. TTE score at 6 months

    Difference in TTE score at 6 months between the two groups

    Measured: 6 months after initial training

  2. TTE duration

    TTE duration at 3 and 6 months

    Measured: 3-4 months and 6 months

  3. Satisfaction score at 6 months

    Satisfaction score over 25 points

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2024
  2. Study start2 May 2021
  3. Primary completion31 Oct 2023
  4. Study completion31 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Multicentered randomized controlled trial.
Masking
Double blind
Who is masked
Care provider, Outcomes assessor
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06442683
Sponsor's protocol ID
ID2259
Acronym
SimuEchoNeo
Status last verified
May 2024
First submitted
27 May 2024
Last updated
17 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Deidentified individual participant data (including data dictionaries) will be made available, in addition to study protocols, the statistical analysis plan, and the informed consent form. The data will be made available upon publication to researchers who provide a methodologically sound proposal for use in achieving the goals of the approved proposal. Proposals should be submitted to amelie.blanchetiere\[at\]unicaen.fr.

Publications

  • Blanchetiere A, Guillouet E, Favrais G, Lardennois C, Bellot A, Savey B. Simulation-Based Echocardiography Training Enhanced Competence and Self-Confidence in Neonatal Residents. Acta Paediatr. 2025 Jul;114(7):1623-1632. doi: 10.1111/apa.70003. Epub 2025 Jan 31.

    PubMed 39891031

Questions about this trial

What is this clinical trial studying?

A study testing TTE simulation-based medical training in people with Simulation-based Training on Residents, run by University Hospital, Caen at 3 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Transthoracic echocardiography (TTE) score at 3 months (time frame: 3 to 4 months after initial training). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06442683, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.

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