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

January 12, 2026 updated by: Misty Melendi, MaineHealth
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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Maine
      • Portland, Maine, United States, 04102
        • MaineHealth Maine Medical Center Portland
        • Contact:
        • Principal Investigator:
          • Misty Melendi, MD
        • Sub-Investigator:
          • Mary Ottolini, MD, MEd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HoloBaby Arm
Participants in this arm will complete their simulations with the HoloBaby simulator technology
Other: HoloBaby Technology
The intervention will be utilizing HoloBaby technology for Neonatal Resuscitation Simulation Education.
Active Comparator: High-fidelity Arm
Participants in this arm will complete their simulations with the traditional high-technology high-fidelity neonatal simulator
Other: High Fidelity Simulator Technology
The intervention will be utilizing HiFi simulator technology for Neonatal Resuscitation Simulation Education.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
13 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MaineHealth

Collaborators

National Institutes of Health (NIH)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 8, 2026

Primary Completion (Estimated)

July 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

November 4, 2025

First Submitted That Met QC Criteria

November 12, 2025

First Posted (Estimated)

November 14, 2025

Study Record Updates

Last Update Posted (Actual)

January 13, 2026

Last Update Submitted That Met QC Criteria

January 12, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2240996

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

data collected is team-based data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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