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

NCT ID: NCT07228494

Last Updated: 2026-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-08

Study Completion Date

2028-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Interprofessional Education Neonatal Resuscitation Rural Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized cluster non-inferiority clinical trial
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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HoloBaby Arm

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

Group Type EXPERIMENTAL

HoloBaby Technology

Intervention Type OTHER

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

High-fidelity Arm

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

Group Type ACTIVE_COMPARATOR

High Fidelity Simulator Technology

Intervention Type OTHER

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

Interventions

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HoloBaby Technology

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

Intervention Type OTHER

High Fidelity Simulator Technology

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* at least 18 years of age
* primary clinical role is either physicians, nurses, or respiratory therapists
* have completed NRPĀ® 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

MaineHealth

OTHER

Sponsor Role lead

Responsible Party

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Misty Melendi

Principal Investigator, Chair of Neonatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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MaineHealth Maine Medical Center Portland

Portland, Maine, United States

Site Status

Countries

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United States

Central Contacts

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Misty Melendi, MD

Role: CONTACT

207-662-2553

Leah Marie Seften

Role: CONTACT

Facility Contacts

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Leah Seften

Role: primary

207-662-6179

Other Identifiers

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2240996

Identifier Type: -

Identifier Source: org_study_id

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