Ventilation Therapy; ComplicationsNeo-VPPNCT06882018
Educational Strategies for Maintaining Technical Skills in Neonatal Resuscitation for the Nursing Team
A study testing Repeated practice guided by peers and Instructor-guided deliberate practice in people with Ventilation Therapy; Complications and Technical Skills, run by Ahmed Moussa at 1 site in Canada.
Trial summary
Despite efforts for initial training in neonatal resuscitation, health professionals show a decline in post-training skills, requiring continuing training. This randomized controlled pilot study will compare the feasibility and preliminary effects of two educational tools in the field, namely the traditional teaching… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ventilation Therapy; Complications, Technical Skills, Nurse's Role
- What is being tested?
- Repeated practice guided by peers and Instructor-guided deliberate practice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteCanada
- Study dates
- 1 Dec 2024to 30 Jun 2025
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Registered or practical nurse working in neonatal intensive care at CHU Sainte-Justine
- At least one year of experience in neonatology care at CHU Sainte-Justine
- Completed the initial neonatal resuscitation training
Who cannot join
- Neonatal transport nurses, due to their particular expertise which may introduce bias.
- Nurse that are instructor for neonatal resuscitation training
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Educational Strategies for Maintaining Technical Skills in Neonatal Resuscitation for the Nursing Team: A Pilot Project
Despite efforts for initial training in neonatal resuscitation, health professionals show a decline in post-training skills, requiring continuing training. This randomized controlled pilot study will compare the feasibility and preliminary effects of two educational tools in the field, namely the traditional teaching method (instructor-assisted deliberate practice) and an educational tool developed during the research project that involves repeated peer-guided practice. Both groups will perform the same educational activity using a mobile training station equipped with the equipment necessary for the PPV. Each session will be of 30 minutes and will be repeated three times over a period of three months.
Read the detailed description
Background :
Despite efforts for initial training in neonatal resuscitation (NR), health professionals show a decline in post-training skills, requiring continuing training. Lack of practice, financial resources and competent worker are the main challenges encountered on the department. However, optimal care in NR, particularly in positive pressure ventilation (PPV) saves lives. Deliberate practice (DP) is a simulation-based instructional strategy known for its effectiveness in maintaining skills. However, DP is limited by the resources and costs linked to the presence of experts. Self-directed, learner-centred approaches could solve these challenges.
This pilot study seeks to compare the proposed tool with a traditional method which is learning through PD guided by an instructor. This feasibility study will make it possible in the future to plan more in-depth research to promote the possibility of generalization.
Th specific research objectives are as follows.
- The primary objective is to document the feasibility of implementing the proposed educational tool in order to maintain technical skills in VPP among practising nurses by comparing it to the traditional method. Feasibility measures include participant satisfaction with the quality of the teaching method, speed of participant recruitment, and participant participation and retention rate.
- The secondary objective is to evaluate whether the participants' confidence in VPP, the propensity to change one's own practice as well as the performance of VPP in the experimental group is similar to the traditional group.
Methods
- Design This randomized controlled pilot study will compare the feasibility and preliminary effects of two educational tools.
- Sample and setting The research project will take place in the neonatal intensive care unit of the Sainte-Justine Hospital Centre (CHUSJ). The target population is the nursing team which includes approximately 240 people. The level of expertise of the sample aims to be as variable as the current population of the neonatal intensive care nursing team.
Convenience sampling due to its pragmatic approach. It allows to recruit accessible participants on time and with limited resources. A stratified randomization will be used to optimize the balance of the groups taking into account the two types of professionals (registered nurses and practical nurses).
The aim is to recruit 50 participants, in order to reach a sample of 40 participants in total considering a potential loss to follow-up of 15%.
Educational activities:
The content of the educational activity focuses on maintaining technical skills in positive pressure ventilation (PPV) during neonatal resuscitation and will be based on the contents of the chapter "Positive pressure ventilation" of the "Neonatal resuscitation manual, 8th edition". This activity consists of putting into practice the actions leading to the VPP sequence, as described in the road map, using the T-piece resuscitation machine (Neopuff) and the self-inflating bag, both of which are available in the clinic. It will take place on a mobile training station equipped with the necessary equipment for VPP. Each session will last 30 minutes and will be held during the participants' work shift, thus benefiting from protected time for training, and will be repeated three times over a three-month period.
The teaching strategy varies between the two groups of participants, which are:
- Intervention group: This approach involves repeated peer-guided practice. Each session will involve two participants, who will support each other using the feedback grid from the first section of the "Neonatal Mask Ventilation Competency Assessment Tool" developed to provide feedback on practising technical skills.
- Control group: In this group, practice is deliberate (PD) and is led by an instructor. Each session will be supervised by an instructor for two to four participants, and the latter will use the same feedback grid as that used in the intervention group to provide feedback.
Demographic and professional questionnaire:
Following consent to participate in the project, participants will have to complete this questionnaire including demographic data, including age by interval and gender, as well as professional data including work shift (day, evening, night, day and night rotation), initial training (college, university, other), the number of months of experience in neonatology, the approximate number of neonatal resuscitations and positive pressure ventilation in which they participated, the approximate number of simulations in neonatal intensive care in which they participated. These data will be used to describe the characteristics of the study sample.
Performance test (before and after training):
To assess changes in technical skills following the intervention, each participant will be assessed before and after the training.
The assessment will be carried out in the simulation room in the neonatal unit and will last 5 minutes. Upon arrival, the participant will be presented with a clinical vignette of a patient requiring positive pressure ventilation (see appendix). This vignette was created by the project researchers based on their experience in the field of neonatology. After two minutes of positive pressure ventilation, the patient will be stabilized and the vignette will end. A short feedback will be provided to the participant after the evaluation.
Two evaluators, including possibly the researcher himself, will complete the evaluation of each video recording, being blind to the participant's group as well as the phase of the study (pre or post training), using the tool "Neonatal Mask Ventilation Competency Assessment Tool". The effectiveness and relevance of this tool in the evaluation of essential clinical skills has been demonstrated, thus justifying its adoption for the project.
Final questionnaire:
This questionnaire will be completed by the participants at the end of their last practical session and is made up of a first part dedicated to the Continuing Professional Development (CPD) questionnaire and a second which assesses the degree of satisfaction, confidence and feasibility of the tool educational. This data will allow evaluation of th feasibility component, confidence as well as the propensity to change one's practice following th intervention.
- Being tested
- Repeated practice guided by peers, Instructor-guided deliberate practice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repeated practice guided by peersOther
This approach involves repeated, peer-guided practice. Each session will involve two participants, who will support each other using the feedback grid from the first section of the "Neonatal Mask Ventilation Competency Assessment Tool" developed by DiLabio et al. (2018) to provide feedback on practicing technical skills.
Instructor-guided deliberate practiceOther
In this group, practice is deliberate (PD) and is led by an instructor. Each session will be supervised by an instructor for two to four participants, and the latter will use the same feedback grid as that used in the intervention group to provide feedback.
| Study group | Role | What they receive |
|---|---|---|
| Repeated practice guided by peers | Experimental | Intervention group which will use the educational tool during repeated practice guided by peers Receives: Other: Repeated practice guided by peers |
| Instructor-guided deliberate practice | Active comparator | A control group that will use the traditional method, instructor-guided deliberate practice Receives: Other: Instructor-guided deliberate practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant satisfaction with the quality of the educational methods assessed by a questionnaire
The questionnaire uses a 1 to 4 likert scale with 1 being the highest satisfaction.
Measured: 6 months
Number of participants that agree to participate
From 0 to 50, 50 being the better outcome
Measured: 6 months
Number of participants that terminate the study (retention rate).
From 0 to 50, 50 being the better outcome
Measured: 6 months
Secondary outcomes (3)
Mean difference in performance of VPP as per the Neonatal Mask Ventilation Competency Assessment Tool (NMVCAT) score
Scale from 0 to 100%, higher means better outcome (performance)
Measured: 6 months
Mean difference in confidence level of participants
Likert scale 1 to 4 with 1 being the highest level of confidence
Measured: 6 months
Propensity to change behaviour score based on the CPD-REACTION questionnaire
Rating from 1 to 7, 7 being the highest propensity to change behaviour
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 posted18 Mar 2025
- Study start1 Dec 2024
- Primary completion1 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilation Therapy; ComplicationsStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahmed Moussa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmed Moussa, St. Justine's Hospital
- Investigators
- Ahmed Moussa, MD, MMEd, Principal investigator, St. Justine's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06882018
- Sponsor's protocol ID
- 2025-7607
- Acronym
- Neo-VPP
- Status last verified
- Jul 2025
- First submitted
- 19 Dec 2024
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Educational Strategies for Maintaining Technical Skills in Neonatal Resuscitation for the Nursing Team: A Pilot Project
- ClinicalTrials.gov ID
- NCT06882018
- Acronym / sponsor ID
- Neo-VPP / 2025-7607
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Ahmed MoussaUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 18 Mar 2025 (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.
Despite efforts for initial training in neonatal resuscitation, health professionals show a decline in post-training skills, requiring continuing training. This randomized controlled pilot study will compare the feasibility and preliminary effects of two educational tools in the field, namely the traditional teaching method (instructor-assisted deliberate practice) and an educational tool developed during the research project that involves repeated peer-guided practice. Both groups will perform the same educational activity using a mobile training station equipped with the equipment necessary for the PPV. Each session will be of 30 minutes and will be repeated three times over a period of three months.
Detailed description
Background :
Despite efforts for initial training in neonatal resuscitation (NR), health professionals show a decline in post-training skills, requiring continuing training. Lack of practice, financial resources and competent worker are the main challenges encountered on the department. However, optimal care in NR, particularly in positive pressure ventilation (PPV) saves lives. Deliberate practice (DP) is a simulation-based instructional strategy known for its effectiveness in maintaining skills. However, DP is limited by the resources and costs linked to the presence of experts. Self-directed, learner-centred approaches could solve these challenges.
This pilot study seeks to compare the proposed tool with a traditional method which is learning through PD guided by an instructor. This feasibility study will make it possible in the future to plan more in-depth research to promote the possibility of generalization.
Th specific research objectives are as follows.
- The primary objective is to document the feasibility of implementing the proposed educational tool in order to maintain technical skills in VPP among practising nurses by comparing it to the traditional method. Feasibility measures include participant satisfaction with the quality of the teaching method, speed of participant recruitment, and participant participation and retention rate.
- The secondary objective is to evaluate whether the participants' confidence in VPP, the propensity to change one's own practice as well as the performance of VPP in the experimental group is similar to the traditional group.
Methods
- Design This randomized controlled pilot study will compare the feasibility and preliminary effects of two educational tools.
- Sample and setting The research project will take place in the neonatal intensive care unit of the Sainte-Justine Hospital Centre (CHUSJ). The target population is the nursing team which includes approximately 240 people. The level of expertise of the sample aims to be as variable as the current population of the neonatal intensive care nursing team.
Convenience sampling due to its pragmatic approach. It allows to recruit accessible participants on time and with limited resources. A stratified randomization will be used to optimize the balance of the groups taking into account the two types of professionals (registered nurses and practical nurses).
The aim is to recruit 50 participants, in order to reach a sample of 40 participants in total considering a potential loss to follow-up of 15%.
Educational activities:
The content of the educational activity focuses on maintaining technical skills in positive pressure ventilation (PPV) during neonatal resuscitation and will be based on the contents of the chapter "Positive pressure ventilation" of the "Neonatal resuscitation manual, 8th edition". This activity consists of putting into practice the actions leading to the VPP sequence, as described in the road map, using the T-piece resuscitation machine (Neopuff) and the self-inflating bag, both of which are available in the clinic. It will take place on a mobile training station equipped with the necessary equipment for VPP. Each session will last 30 minutes and will be held during the participants' work shift, thus benefiting from protected time for training, and will be repeated three times over a three-month period.
The teaching strategy varies between the two groups of participants, which are:
- Intervention group: This approach involves repeated peer-guided practice. Each session will involve two participants, who will support each other using the feedback grid from the first section of the "Neonatal Mask Ventilation Competency Assessment Tool" developed to provide feedback on practising technical skills.
- Control group: In this group, practice is deliberate (PD) and is led by an instructor. Each session will be supervised by an instructor for two to four participants, and the latter will use the same feedback grid as that used in the intervention group to provide feedback.
Demographic and professional questionnaire:
Following consent to participate in the project, participants will have to complete this questionnaire including demographic data, including age by interval and gender, as well as professional data including work shift (day, evening, night, day and night rotation), initial training (college, university, other), the number of months of experience in neonatology, the approximate number of neonatal resuscitations and positive pressure ventilation in which they participated, the approximate number of simulations in neonatal intensive care in which they participated. These data will be used to describe the characteristics of the study sample.
Performance test (before and after training):
To assess changes in technical skills following the intervention, each participant will be assessed before and after the training.
The assessment will be carried out in the simulation room in the neonatal unit and will last 5 minutes. Upon arrival, the participant will be presented with a clinical vignette of a patient requiring positive pressure ventilation (see appendix). This vignette was created by the project researchers based on their experience in the field of neonatology. After two minutes of positive pressure ventilation, the patient will be stabilized and the vignette will end. A short feedback will be provided to the participant after the evaluation.
Two evaluators, including possibly the researcher himself, will complete the evaluation of each video recording, being blind to the participant's group as well as the phase of the study (pre or post training), using the tool "Neonatal Mask Ventilation Competency Assessment Tool". The effectiveness and relevance of this tool in the evaluation of essential clinical skills has been demonstrated, thus justifying its adoption for the project.
Final questionnaire:
This questionnaire will be completed by the participants at the end of their last practical session and is made up of a first part dedicated to the Continuing Professional Development (CPD) questionnaire and a second which assesses the degree of satisfaction, confidence and feasibility of the tool educational. This data will allow evaluation of th feasibility component, confidence as well as the propensity to change one's practice following th intervention.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Repeated practice guided by peers | Experimental | Other: Repeated practice guided by peersIntervention group which will use the educational tool during repeated practice guided by peers |
| Instructor-guided deliberate practice | Active comparator | Other: Instructor-guided deliberate practiceA control group that will use the traditional method, instructor-guided deliberate practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Registered or practical nurse working in neonatal intensive care at CHU Sainte-Justine
- At least one year of experience in neonatology care at CHU Sainte-Justine
- Completed the initial neonatal resuscitation training
Key exclusion criteria (2 listed)
- Neonatal transport nurses, due to their particular expertise which may introduce bias.
- Nurse that are instructor for neonatal resuscitation training
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 |
|---|---|---|
| Repeated practice guided by peersThis approach involves repeated, peer-guided practice. Each session will involve two participants, who will support each other using the feedback grid from the first section of the "Neonatal Mask Ventilation Competency Assessment Tool" developed by DiLabio et al. (2018) to provide feedback on practicing technical skills. | Other | Repeated practice guided by peers |
| Instructor-guided deliberate practiceIn this group, practice is deliberate (PD) and is led by an instructor. Each session will be supervised by an instructor for two to four participants, and the latter will use the same feedback grid as that used in the intervention group to provide feedback. | Other | Instructor-guided deliberate practice |
Primary outcome
Participant satisfaction with the quality of the educational methods assessed by a questionnaire
Time frame: 6 months
The questionnaire uses a 1 to 4 likert scale with 1 being the highest satisfaction.
Number of participants that agree to participate
Time frame: 6 months
From 0 to 50, 50 being the better outcome
Number of participants that terminate the study (retention rate).
Time frame: 6 months
From 0 to 50, 50 being the better outcome
3 secondary outcomes
Mean difference in performance of VPP as per the Neonatal Mask Ventilation Competency Assessment Tool (NMVCAT) score
Time frame: 6 months
Mean difference in confidence level of participants
Time frame: 6 months
Propensity to change behaviour score based on the CPD-REACTION questionnaire
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 16 Jul 2025.
- Individual participant dataSharing planned: No
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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.
Ahmed Moussa, MD, MMEd principal investigator
St. Justine's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repeated practice guided by peers and Instructor-guided deliberate practice in people with Ventilation Therapy; Complications and Technical Skills, run by Ahmed Moussa at 1 site in Canada.
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 3 inclusion and 2 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 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
Participant satisfaction with the quality of the educational methods assessed by a questionnaire (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jul 2025.