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Enrolling by invitationNCT07228494Updated Oct 5, 2026

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

An interventional study of HoloBaby Technology and High Fidelity Simulator Technology in Interprofessional Education, Neonatal Resuscitation and Rural Health, sponsored by MaineHealth. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-05.

Sponsored by MaineHealth · Not applicable, Interventional, and Other

Updated Oct 5, 2026Now Enrolling by invitationStart date moved+1 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Interprofessional Education
  • Neonatal Resuscitation
  • Rural Health

Keywords

  • HoloBaby
  • Neonatal resuscitation
  • interprofessional education
  • medical education
  • neonatal readiness
  • technology development
  • mixed reality
03

In context

Lead sponsor

MaineHealth is the lead sponsor of 36 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Oct 5, 2026. See what changed

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • at least 18 years of age
  • primary clinical role is either a physician, nurse, or respiratory therapist
  • have completed NRP® certification within the two years prior to enrollment
  • attend deliveries at participating hospital in study

Exclusion criteria

Exclusion Criteria:

- photosensitive epilepsy

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
400 participants (estimated)

Study arms

  • Experimental
    HoloBaby Arm

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

    Other: HoloBaby Technology

  • 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

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.

06

What researchers measure

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

    Time frame: 13 months

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No — data collected is team-based data

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Started Dec 2025 (actual). Primary completion is estimated for Jul 2028, 31 months after the start.

Start moved once since we started tracking on Sep 25, 2026: Jan 2026 → Dec 2025, on Oct 5, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Nov 4, 2025
First posted
Nov 14, 2025
StartActual
Dec 22, 2025was Jan 2026
Primary completionEst.
Jul 31, 2028
CompletionEst.
Dec 31, 2028
Last update
Oct 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Enrolling by invitation
changed Oct 5, 2026
Start date
Jan 8, 2026→Dec 22, 2025 (actual)
Oct 5, 2026
Eligibility
1 inclusion criterion edited; 1 exclusion criterion added, 1 removed
What changed in the criteria
Inclusion criteria
  • Editedprimary clinical role is either physiciansa physician, nursesnurse, or respiratory therapiststherapist
Exclusion criteria
  • Removed- chronic neck pain, a previous neck injury that requires ongoing precautions, severe motion sickness or vertigo, and/or photosensitive epilepsy
  • Added- photosensitive epilepsy
Oct 5, 2026
Contact
No study contact listed any more: removed M•••@mainehealth.org · •••2553; removed l•••@mainehealth.org
Oct 5, 2026
Site contacts
Changed at 1 site. See the sites
Show the site
  • MaineHealth Maine Medical Center Portland · Portland, United StatesContact removed l•••@mainehealth.org · •••6179Contact removed (no phone or email listed)Contact removed (no phone or email listed)
Oct 5, 2026
Show all 1 update
  1. Oct 5, 2026
    Not yet recruiting→Enrolling by invitation
    Start date Jan 8, 2026→Dec 22, 2025 (now actual)
    Eligibility 1 inclusion criterion edited; 1 exclusion criterion added, 1 removed
    What changed in the criteria
    Inclusion criteria
    • Editedprimary clinical role is either physiciansa physician, nursesnurse, or respiratory therapiststherapist
    Exclusion criteria
    • Removed- chronic neck pain, a previous neck injury that requires ongoing precautions, severe motion sickness or vertigo, and/or photosensitive epilepsy
    • Added- photosensitive epilepsy
    Contact No study contact listed any more: removed M•••@mainehealth.org · •••2553; removed l•••@mainehealth.org
    Site contacts Changed at 1 site. See the sites
    Show the site
    • MaineHealth Maine Medical Center Portland · Portland, United StatesContact removed l•••@mainehealth.org · •••6179Contact removed (no phone or email listed)Contact removed (no phone or email listed)
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07228494
Lead sponsor
MaineHealth
Collaborators
National Institutes of Health (NIH)
Responsible party
Misty Melendi (Principal Investigator, Chair of Neonatology, MaineHealth) — Principal investigator
First posted
Nov 14, 2025
Start date
Dec 22, 2025
Primary completion
Jul 31, 2028 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Oct 5, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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