SimulationMAXnéonatNCT05613530
Mobile Application as a Clinical Decision Support Tool for Neonatal Resuscitation in the Delivery Room
A study testing MAX NEONAT in people with Simulation, run by Erasme University Hospital at 1 site in France.
Trial summary
The need for neonatal cardiopulmonary resuscitation in the delivery room is rare with less than 1% of newborns requiring advanced resuscitation. The use of clinical decision support tools to guide practitioners on medical procedure steps is recognized by the medical community. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Simulation
- What is being tested?
- MAX NEONAT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 19 May 2021to 1 May 2022
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All pediatric residents in Lyon and Caen University with at least a three-month clinical experience in a neonatal intensive care unit and one or more high fidelity neonatal resuscitation simulation sessions participation
- All midwife students in Lyon and Caen which had benefited from teaching classes on neonatal resuscitation
Who cannot join
- Participants who didn't attend one of the scheduled study sessions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mobile Application (Max NEONAT) as a Clinical Support Tool for Neonatal Resuscitation in the Delivery Room: A Simulation-based Bicentric Randomized Controlled Trial.
The need for neonatal cardiopulmonary resuscitation in the delivery room is rare with less than 1% of newborns requiring advanced resuscitation. The use of clinical decision support tools to guide practitioners on medical procedure steps is recognized by the medical community. In this randomized bi-centric controlled study, we investigate the effect of a mobile phone application on technical and non-technical performance of student trinomials managing simulated critical neonatal events
Read the detailed description
The need for neonatal cardiopulmonary resuscitation in the delivery room is rare with less than 1% of newborns requiring advanced resuscitation: Approximately 85% of babies born at term will initiate breathing spontaneously at birth. An additional 10% will do so in response to stimulation and drying. However, approximately 5% of term infants receive positive-pressure ventilation to successfully transition, 2% are intubated, 0.1% receive cardiac compressions, and 0.05% receive compressions with Epinephrine. These events are rare but stressful and require fast response. High stress impairs cognitive skills, including decision making, short-term memory, knowledge recall, and situational attention. In order to help practitioners, guidelines and algorithm exists: The neonatal resuscitation program (NRP) and International Liaison Committee on Resuscitation (ILCOR) algorithm outlines essential steps to take to assist a neonate immediately after birth. ILCOR algorithm poster is present in every delivery room in France. Nevertheless, studies have shown a 16-55% error rate in adherence to the NRP algorithm. Despite periodic training skills deterioration, technical performance, and aptitude to follow recommendations decline over time.
The use of cognitive aids might be a solution to prevent errors in critical situation. Cognitive aids are defined as "prompts designed to help users complete a task or series of tasks." The design of cognitive aids includes posters, checklists, mnemonics, or digital tools like computer programs or smartphone applications. Poster or checklist cognitive aids are widely used to help health care to follow standardized procedures while facing high-cognitive loads situations. Many digital cognitive aids have been developed in intensive care (cardiac arrest) and anesthesiology both in adult and pediatric fields. They have been shown to improve technical skills along with guideline adherence in adult's study. Influence of cognitive aids on technical and nontechnical skills has not been investigated extensively and is still controversial in pediatrics. In neonatology some studies exist but with discordant results. MAX (Medical Assistance eXpert) is a mobile French cognitive aid available on smartphone or tablet. The use of MAX has been shown to improve technical and nontechnical skill in previous adult studies. To evaluate the usefulness of digital cognitive aid in neonatal critical situations, ILCOR 2020 algorithm was included in MAX. A previous unpublished pilot study in neonatal simulated cardiopulmonary arrest shown feasibility in trinomials and improvement in technical skill.
We performed an unblinded randomized trial comparing the use of a digital, hand-held, cognitive aid (a mobile application named "MAX NEONAT") and the ILCOR 2020 algorithm poster, vs. without cognitive aid, to test the hypothesis that MAX NEONAT could improve technical performance and affect non-technical performance of pediatric residents and mid wife-students facing simulated neonatal cardiac arrest.
- Conditions
- Simulation
- Being tested
- MAX NEONAT, standard of care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAX NEONATBehavioural
Participants use a digital, hand-held, cognitive aid (a mobile application named "MAX NEONAT") and the ILCOR 2020 algorithm poster.
This group consists of a resident in pediatrics + 2 midwifes.
standard of careBehavioural
no cognitive aid but poster/paper only
| Study group | Role | What they receive |
|---|---|---|
| digital MAX néonat (intervention group or " MAX + group") | Experimental | Participants use a digital, hand-held, cognitive aid (a mobile application named "MAX NEONAT") and the ILCOR 2020 algorithm poster.
This group consists of a resident in pediatrics + 2 midwifes. Receives: Behavioral: MAX NEONAT |
| MAX néonat on poster/paper (control group or " MAX - group") | Active comparator | Participants have no cognitive aid Receives: Behavioral: standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is a technical performance score, adapted from of a previously published checklist score. The technical score follows the (International Liaison Committee on Resuscitation recommendations (ILCOR).
the NRP checklist ( Neonatal Rescucitation Program) score we utilized is a previously published technical performance score adapted from the ILCOR 2020 recommendations. This revised NRP score is composed of 27 points. For each action, trinomials are given a score of 0 for not performing the action, 1 for performing the task correctly and in order.
Measured: DAY 1
Secondary outcomes (1)
non-technical skills
non-technical skills, evaluated by an adaptation of a previously published checklist score. The non-technical score includes three categories: leadership, teamwork and task management. The score has a total of 36 points. A questionnaire evaluating the functionality and usefulness of the mobile phone application will be analyzed.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start19 May 2021
- Primary completion1 May 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SimulationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hospices Civils de Lyon
- Responsible party
- Principal investigator, Alexandre Joosten, MD PhD, Erasme University Hospital
- Investigators
- Anne Beissel, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05613530
- Sponsor's protocol ID
- MAX néonat
- Acronym
- MAXnéonat
- Status last verified
- Nov 2022
- First submitted
- 6 Nov 2022
- Last updated
- 23 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Application (Max NEONAT) as a Clinical Support Tool for Neonatal Resuscitation in the Delivery Room: A Simulation-based Bicentric Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05613530
- Acronym / sponsor ID
- MAXnéonat / MAX néonat
- Conditions
- Simulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Collaborators
- Hospices Civils de Lyon
- Study start
- 19 May 2021 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 14 Nov 2022 (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.
The need for neonatal cardiopulmonary resuscitation in the delivery room is rare with less than 1% of newborns requiring advanced resuscitation. The use of clinical decision support tools to guide practitioners on medical procedure steps is recognized by the medical community. In this randomized bi-centric controlled study, we investigate the effect of a mobile phone application on technical and non-technical performance of student trinomials managing simulated critical neonatal events
Detailed description
The need for neonatal cardiopulmonary resuscitation in the delivery room is rare with less than 1% of newborns requiring advanced resuscitation: Approximately 85% of babies born at term will initiate breathing spontaneously at birth. An additional 10% will do so in response to stimulation and drying. However, approximately 5% of term infants receive positive-pressure ventilation to successfully transition, 2% are intubated, 0.1% receive cardiac compressions, and 0.05% receive compressions with Epinephrine. These events are rare but stressful and require fast response. High stress impairs cognitive skills, including decision making, short-term memory, knowledge recall, and situational attention. In order to help practitioners, guidelines and algorithm exists: The neonatal resuscitation program (NRP) and International Liaison Committee on Resuscitation (ILCOR) algorithm outlines essential steps to take to assist a neonate immediately after birth. ILCOR algorithm poster is present in every delivery room in France. Nevertheless, studies have shown a 16-55% error rate in adherence to the NRP algorithm. Despite periodic training skills deterioration, technical performance, and aptitude to follow recommendations decline over time.
The use of cognitive aids might be a solution to prevent errors in critical situation. Cognitive aids are defined as "prompts designed to help users complete a task or series of tasks." The design of cognitive aids includes posters, checklists, mnemonics, or digital tools like computer programs or smartphone applications. Poster or checklist cognitive aids are widely used to help health care to follow standardized procedures while facing high-cognitive loads situations. Many digital cognitive aids have been developed in intensive care (cardiac arrest) and anesthesiology both in adult and pediatric fields. They have been shown to improve technical skills along with guideline adherence in adult's study. Influence of cognitive aids on technical and nontechnical skills has not been investigated extensively and is still controversial in pediatrics. In neonatology some studies exist but with discordant results. MAX (Medical Assistance eXpert) is a mobile French cognitive aid available on smartphone or tablet. The use of MAX has been shown to improve technical and nontechnical skill in previous adult studies. To evaluate the usefulness of digital cognitive aid in neonatal critical situations, ILCOR 2020 algorithm was included in MAX. A previous unpublished pilot study in neonatal simulated cardiopulmonary arrest shown feasibility in trinomials and improvement in technical skill.
We performed an unblinded randomized trial comparing the use of a digital, hand-held, cognitive aid (a mobile application named "MAX NEONAT") and the ILCOR 2020 algorithm poster, vs. without cognitive aid, to test the hypothesis that MAX NEONAT could improve technical performance and affect non-technical performance of pediatric residents and mid wife-students facing simulated neonatal cardiac arrest.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| digital MAX néonat (intervention group or " MAX + group") | Experimental | Behavioral: MAX NEONATParticipants use a digital, hand-held, cognitive aid (a mobile application named "MAX NEONAT") and the ILCOR 2020 algorithm poster. This group consists of a resident in pediatrics + 2 midwifes. |
| MAX néonat on poster/paper (control group or " MAX - group") | Active comparator | Behavioral: standard of careParticipants have no cognitive aid |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All pediatric residents in Lyon and Caen University with at least a three-month clinical experience in a neonatal intensive care unit and one or more high fidelity neonatal resuscitation simulation sessions participation
- All midwife students in Lyon and Caen which had benefited from teaching classes on neonatal resuscitation
Key exclusion criteria (1 listed)
- Participants who didn't attend one of the scheduled study sessions.
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 |
|---|---|---|
| MAX NEONATParticipants use a digital, hand-held, cognitive aid (a mobile application named "MAX NEONAT") and the ILCOR 2020 algorithm poster. This group consists of a resident in pediatrics + 2 midwifes. | Behavioural | digital MAX néonat (intervention group or " MAX + group") |
| standard of careno cognitive aid but poster/paper only | Behavioural | MAX néonat on poster/paper (control group or " MAX - group") |
Primary outcome
The primary outcome is a technical performance score, adapted from of a previously published checklist score. The technical score follows the (International Liaison Committee on Resuscitation recommendations (ILCOR).
Time frame: DAY 1
the NRP checklist ( Neonatal Rescucitation Program) score we utilized is a previously published technical performance score adapted from the ILCOR 2020 recommendations. This revised NRP score is composed of 27 points. For each action, trinomials are given a score of 0 for not performing the action, 1 for performing the task correctly and in order.
1 secondary outcome
non-technical skills
Time frame: Day 1
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 23 Nov 2022.
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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.
Anne Beissel, MD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MAX NEONAT in people with Simulation, run by Erasme University Hospital at 1 site 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 2 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 23 Nov 2022. 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 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?
The primary outcome is a technical performance score, adapted from of a previously published checklist score. The technical score follows the (International Liaison Committee on Resuscitation recommendations (ILCOR). (time frame: DAY 1). 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 23 Nov 2022.