Comparative Study of Simulation Technologies for Use in Neonatal Resuscitation Training for Rural Hospitals

NCT07228494 | Not Yet Recruiting

• 1 other identifier: 2240996
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Interprofessional Education; Neonatal Resuscitation; Rural Health

Keywords

HoloBaby; Neonatal resuscitation; interprofessional education; medical education; neonatal readiness; technology development; mixed reality

Outcome Measures

Primary Outcomes (1)

• 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

  13 months

Study Arms (2)

HoloBaby Arm

EXPERIMENTAL

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

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

Other: High Fidelity Simulator Technology

Interventions

HoloBaby Technology OTHER

The intervention will be utilizing HoloBaby technology for Neonatal Resuscitation Simulation Education.

HoloBaby Arm

High Fidelity Simulator Technology OTHER

The intervention will be utilizing HiFi simulator technology for Neonatal Resuscitation Simulation Education.

High-fidelity Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• at least 18 years of age
• 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

You may not qualify if:

• \- chronic neck pain, a previous neck injury that requires ongoing precautions, severe motion sickness or vertigo, and/or photosensitive epilepsy

Sponsors & Collaborators

• MaineHealth: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

MaineHealth Maine Medical Center Portland

Portland, Maine, 04102, United States

Location

Central Study Contacts

Misty Melendi, MD

CONTACT

207-662-2553; Misty.Melendi@MaineHealth.org

Leah Marie Seften

CONTACT

leah.seften@mainehealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Chair of Neonatology

Model Details: randomized cluster non-inferiority clinical trial

Study Record Dates

• First Submitted: November 4, 2025
• First Posted: November 14, 2025
• Study Start: January 8, 2026
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 13, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)