Interprofessional EducationNCT07228494
Comparative Study of Simulation Technologies for Use in Neonatal Resuscitation Training for Rural Hospitals
A study testing HoloBaby Technology and High Fidelity Simulator Technology in people with Interprofessional Education and Neonatal Resuscitation, run by MaineHealth at 1 site in United States.
Trial summary
Conduct a randomized cluster non-inferiority clinical trial with teams of interprofessional neonatal clinicians from rural delivery hospitals. In this trial we will compare HoloBaby, a novel mixed reality simulator technology, to traditional high-technology simulator technology. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interprofessional Education, Neonatal Resuscitation, Rural Health
- What is being tested?
- HoloBaby Technology and High Fidelity Simulator Technology
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Dec 2025to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- at least 18 years of age
- primary clinical role is either a physician, nurse, or respiratory therapist
- have completed NRP® certification within the two years prior to enrollment
- attend deliveries at participating hospital in study
Who cannot join
- photosensitive epilepsy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
MaineHealth Maine Medical Center Portland
Portland, Maine, 04102
About this study
Conduct a randomized cluster non-inferiority clinical trial with teams of interprofessional neonatal clinicians from rural delivery hospitals. In this trial we will compare HoloBaby, a novel mixed reality simulator technology, to traditional high-technology simulator technology.
- Being tested
- HoloBaby Technology, High Fidelity Simulator Technology
- Keywords
- HoloBaby, Neonatal resuscitation, interprofessional education, medical education, neonatal readiness, technology development, mixed reality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HoloBaby TechnologyOther
The intervention will be utilizing HoloBaby technology for Neonatal Resuscitation Simulation Education.
High Fidelity Simulator TechnologyOther
The intervention will be utilizing HiFi simulator technology for Neonatal Resuscitation Simulation Education.
| Study group | Role | What they receive |
|---|---|---|
| HoloBaby Arm | Experimental | Participants in this arm will complete their simulations with the HoloBaby simulator technology Receives: Other: HoloBaby Technology |
| High-fidelity Arm | Active comparator | Participants in this arm will complete their simulations with the traditional high-technology high-fidelity neonatal simulator Receives: Other: High Fidelity Simulator Technology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Team-based NRP® Adherence Score
the change in resuscitation performance at each site over time; NRP score will be measured utilizing an NRP adherence assessment tool that has been published with validity evidence. the adherence score will be presented as a percentage (out of 100) and higher scores indicate a higher adherence to NRP guidelines thus indicating a better resuscitation performance
Measured: 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2025
- Study start22 Dec 2025
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interprofessional EducationStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized cluster non-inferiority clinical trial
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MaineHealth
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Misty Melendi, MaineHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07228494
- Sponsor's protocol ID
- 2240996
- Status last verified
- Oct 2026
- First submitted
- 4 Nov 2025
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: data collected is team-based data
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Simulation Technologies for Use in Neonatal Resuscitation Training for Rural Hospitals
- ClinicalTrials.gov ID
- NCT07228494
- Acronym / sponsor ID
- 2240996
- Keywords
- HoloBaby, Neonatal resuscitation, interprofessional education, medical education, neonatal readiness, technology development, mixed reality
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- MaineHealthUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 22 Dec 2025 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 14 Nov 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.
Conduct a randomized cluster non-inferiority clinical trial with teams of interprofessional neonatal clinicians from rural delivery hospitals. In this trial we will compare HoloBaby, a novel mixed reality simulator technology, to traditional high-technology simulator technology.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized cluster non-inferiority clinical trial
| Arm | Type | Receives |
|---|---|---|
| HoloBaby Arm | Experimental | Other: HoloBaby TechnologyParticipants in this arm will complete their simulations with the HoloBaby simulator technology |
| High-fidelity Arm | Active comparator | Other: High Fidelity Simulator TechnologyParticipants in this arm will complete their simulations with the traditional high-technology high-fidelity neonatal simulator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- at least 18 years of age
- primary clinical role is either a physician, nurse, or respiratory therapist
- have completed NRP® certification within the two years prior to enrollment
- attend deliveries at participating hospital in study
Key exclusion criteria (1 listed)
- photosensitive epilepsy
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 |
|---|---|---|
| HoloBaby TechnologyThe intervention will be utilizing HoloBaby technology for Neonatal Resuscitation Simulation Education. | Other | HoloBaby Arm |
| High Fidelity Simulator TechnologyThe intervention will be utilizing HiFi simulator technology for Neonatal Resuscitation Simulation Education. | Other | High-fidelity Arm |
Primary outcome
Team-based NRP® Adherence Score
Time frame: 13 months
the change in resuscitation performance at each site over time; NRP score will be measured utilizing an NRP adherence assessment tool that has been published with validity evidence. the adherence score will be presented as a percentage (out of 100) and higher scores indicate a higher adherence to NRP guidelines thus indicating a better resuscitation performance
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No. data collected is team-based data
Related trials for Interprofessional Education
Recruiting
Interprofessional Education Programme for Nursing and Physiotherapy Students Providing Home-Based Care to Older Adults
Frailty at Older Adults
Active, not recruiting
Procedure Manual-Based Simulation Training to Improve Operating Room Nurses' Core Competencies
Core Competency, Patient Safety
RecruitingObservational study
Impact of IPE in Multidisciplinary Primary Care Centres on Collaborative Competency of Healthcare Students (FLIRT-MSP)
Interprofessional Education
Not yet recruiting
THE EFFECT OF SIMULATION-BASED INTERPROFESSIONAL EDUCATION ON ATTITUDES TOWARD TEAMWORK
No Specific Diseases or Conditions Are Being Studied
Active, not recruiting
The Maximizing Extubation Outcomes Through Educational and Organizational Research (METEOR) Trial
Acute Respiratory Failure, Airway Extubation
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HoloBaby Technology and High Fidelity Simulator Technology in people with Interprofessional Education and Neonatal Resuscitation, run by MaineHealth at 1 site in United States.
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 4 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: enrolling by invitation, as of the sponsor's last update on 5 Oct 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Team-based NRP® Adherence Score (time frame: 13 months). 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 5 Oct 2026.