Simulation Technologies for Neonatal Resuscitation

Overseen By Leah Marie Seften

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: MaineHealth

Disqualifiers: Chronic neck pain, Vertigo, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new methods to train medical teams in providing emergency care to newborns immediately after birth. It compares two training tools: a traditional high-tech simulator (High Fidelity Simulator Technology) and a new mixed reality tool called HoloBaby. The researchers aim to determine if HoloBaby is as effective as traditional methods. Ideal participants include doctors, nurses, or respiratory therapists who have worked in childbirth settings and completed specific training within the past two years. As an unphased trial, this study allows participants to contribute to innovative training methods that could revolutionize newborn emergency care.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these simulation technologies are safe for neonatal resuscitation training?

Research has shown that HoloBaby, a new mixed reality simulator, was tested in earlier studies. Participants found it easier to recognize signs of shock with HoloBaby compared to traditional simulators, suggesting its effectiveness and safety for training.

These studies reported no negative effects from using HoloBaby, indicating it is likely well-tolerated by users. As this trial focuses on training with simulation technology rather than direct medical treatment, the risks to participants are minimal. This should reassure participants about the safety of trying the HoloBaby simulation in this study. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative simulation technologies for neonatal resuscitation that could transform training methods. The HoloBaby technology uses augmented reality to create a highly immersive and interactive learning environment, which could enhance the realism and effectiveness of resuscitation training. Unlike traditional high-fidelity simulators that rely on physical models, HoloBaby offers a more flexible and engaging experience by overlaying digital elements onto the real world, allowing for dynamic scenario adjustments and a deeper understanding of neonatal care. This trial aims to find out if these advanced technologies can improve the skills and confidence of healthcare providers, potentially leading to better outcomes in real-world resuscitation situations.

What evidence suggests that this trial's simulator technologies could be effective for neonatal resuscitation?

This trial will compare the effectiveness of two simulation technologies for neonatal resuscitation. Studies have shown that HoloBaby, a mixed reality simulator for newborn emergency care, matches traditional high-tech simulators in helping users understand situations. Participants in the HoloBaby Arm will use this technology, which has been found to improve recognition of shock signs better than traditional methods. Meanwhile, participants in the High-fidelity Arm will use traditional high-technology high-fidelity neonatal simulators. Training with simulators like HoloBaby and other advanced tools has been widely used and has shown positive results in education and patient care. This suggests that HoloBaby could be a valuable tool for training healthcare workers in newborn emergency care, especially in rural areas. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for teams of healthcare professionals from rural hospitals who specialize in newborn care. It's designed to see if a new mixed reality simulator (HoloBaby) is as good as the traditional high-tech simulators they currently use for neonatal resuscitation training.

Inclusion Criteria

Primary clinical role is either physicians, nurses, or respiratory therapists

Have completed NRP® certification within the two years prior to enrollment

Attend deliveries at participating hospital in study

Exclusion Criteria

Previous neck injury that requires ongoing precautions

Severe motion sickness or vertigo

Photosensitive epilepsy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training

Participants undergo training using either the HoloBaby simulator or traditional high-fidelity simulator

13 months

Follow-up

Participants are monitored for changes in resuscitation performance over time

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• High Fidelity Simulator Technology
• HoloBaby Technology

Trial Overview

The study compares two types of simulation technologies: HoloBaby, which uses mixed reality, and a conventional High Fidelity Simulator. Teams are randomly chosen to train with one technology or the other, and their performance in neonatal resuscitation will be evaluated.

How Is the Trial Designed?

Group I: HoloBaby Arm Experimental Treatment 1 Intervention

Participants in this arm will complete their simulations with the HoloBaby simulator technology

Group II: High-fidelity Arm Active Control 1 Intervention

Participants in this arm will complete their simulations with the traditional high-technology high-fidelity neonatal simulator

Who Is Running the Clinical Trial?

MaineHealth

Lead Sponsor

Trials

76

Recruited

43,800+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40762560/

A Mixed Methods Pilot Study of Neonatal Resuscitation ...

Conclusion: The MR simulator, HoloBaby, offers the experience of simulation-based team training and matches the HTM in user ability to assess ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07228494

Comparative Study of Simulation Technologies for Use in ...

In this trial we will compare HoloBaby, a novel mixed reality simulator technology, to traditional high-technology simulator technology. Official Title.

3.

researchgate.net

researchgate.net/publication/394318018_A_Mixed_Methods_Pilot_Study_of_Neonatal_Resuscitation_Team_Training_for_Rural_Providers_Using_HoloBaby_a_Mixed_Reality_Prototype_Simulator

A Mixed Methods Pilot Study of Neonatal Resuscitation ...

Results Participants reported that they were better able to effectively recognize shock in HoloBaby over the HTM. No other significant ...

4.

linkedin.com

linkedin.com/posts/mainehealth_mainehealth-secures-grant-to-enhance-newborn-activity-7374893568680955904-q5K5

MaineHealth gets $2.8M NIH grant for neonatal ...

MaineHealth has received a $2.8 million grant from the NIH to develop technology designed to improve neonatal resuscitation training.

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S2666520425000128

Potential benefits and challenges of simulation-based ...

Simulation-based neonatal resuscitation training has been implemented worldwide with good educational and clinical results. Simulation-based competition ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07228494?aggFilters=status%3A%2Cphase%3A

Comparative Study of Simulation Technologies for Use in ...

In this trial we will compare HoloBaby, a novel mixed reality simulator technology, to traditional high-technology simulator technology. Official Title.

7.

mainehealth.org

mainehealth.org/news/2025/09/nih-funds-mainehealth-research-project-aimed-saving-newborn-lives

NIH funds MaineHealth research project aimed at saving ...

As a result, newborns born at rural hospitals who require resuscitation are at four times the risk of birth asphyxia, a preventable cause of ...