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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07228494
Enrollment
400
Registered
2025-11-14
Start date
2026-01-08
Completion date
2028-12-31
Last updated
2026-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Interprofessional Education, Neonatal Resuscitation, Rural Health

Keywords

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

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.

Interventions

OTHERHoloBaby Technology

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

OTHERHigh Fidelity Simulator Technology

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

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
MaineHealth
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Intervention model description

randomized cluster non-inferiority clinical trial

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Team-based NRP® Adherence Score13 monthsthe 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

Countries

United States

Contacts

Primary ContactMisty Melendi, MD
Misty.Melendi@MaineHealth.org207-662-2553
Backup ContactLeah Marie Seften
leah.seften@mainehealth.org

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026