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.
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
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.
- Conditions
- Simulation-based Training on Residents
- 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 group | Role | What they receive |
|---|---|---|
| Simulation group | Experimental | Theorical training, simulation-based training and bedside training Receives: Diagnostic Test: TTE simulation-based medical training |
| Control group | No intervention | Theorical and bedside training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
TTE score at 6 months
Difference in TTE score at 6 months between the two groups
Measured: 6 months after initial training
TTE duration
TTE duration at 3 and 6 months
Measured: 3-4 months and 6 months
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.
- First posted4 Jun 2024
- Study start2 May 2021
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Simulation-based Training on ResidentsStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Simulation-based Neonatal Echocardiography Training: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06442683
- Acronym / sponsor ID
- SimuEchoNeo / ID2259
- Conditions
- Simulation-based Training on Residents
- Keywords
- Neonatology, Simulation-based training, Echocardiography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 2 May 2021 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 4 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Multicentered randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Simulation group | Experimental | Diagnostic Test: TTE simulation-based medical trainingTheorical training, simulation-based training and bedside training |
| Control group | No intervention | –Theorical and bedside training |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (1 listed)
- Residents who had already received a TTE training (cardiology or cardiopediatrics 6-month residency or postgraduate training in cardiology or echocardiography)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TTE simulation-based medical traininghalf-day simulation-based neonatal echocardiography training. | Diagnostic test | Simulation group |
Primary outcome
Transthoracic echocardiography (TTE) score at 3 months
Time frame: 3 to 4 months after initial training
Difference in TTE score at 3 months between the two groups
3 secondary outcomes
TTE score at 6 months
Time frame: 6 months after initial training
TTE duration
Time frame: 3-4 months and 6 months
Satisfaction score at 6 months
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Results publication: PubMed 39891031Blanchetiere 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
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.