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NCT Number: NCT07228494

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

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.

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Key information

Conditions

Interprofessional Education Neonatal Resuscitation Rural Health

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MaineHealth Maine Medical Center Portland

Portland, Maine, 04102, United States

Location contact

Leah Seften

CONTACT

[email protected]

207-662-6179

Mary Ottolini, MD, MEd

SUB_INVESTIGATOR

Misty Melendi, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HoloBaby Technology

Other

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

High Fidelity Simulator Technology

Other

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

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Leah Marie Seften

CONTACT

[email protected]

Misty Melendi, MD

CONTACT

[email protected]

207-662-2553

Sponsors and collaborators

Lead sponsor

MaineHealth

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Nov 14, 2025
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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