Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 11:46 PM
Study NCT ID:
NCT07228494
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-14
First Post:
2025-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Study of Simulation Technologies for Use in Neonatal Resuscitation Training for Rural Hospitals
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomized cluster non-inferiority clinical trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-12', 'studyFirstSubmitDate': '2025-11-04', 'studyFirstSubmitQcDate': '2025-11-12', 'lastUpdatePostDateStruct': {'date': '2025-11-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Team-based NRP® Adherence Score', 'timeFrame': '13 months', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HoloBaby', 'Neonatal resuscitation', 'interprofessional education', 'medical education', 'neonatal readiness', 'technology development', 'mixed reality'], 'conditions': ['Interprofessional Education', 'Neonatal Resuscitation', 'Rural Health']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* at least 18 years of age\n* primary clinical role is either physicians, nurses, or respiratory therapists\n* have completed NRP® certification within the two years prior to enrollment\n* attend deliveries at participating hospital in study\n\nExclusion Criteria:\n\n\\- chronic neck pain, a previous neck injury that requires ongoing precautions, severe motion sickness or vertigo, and/or photosensitive epilepsy'}, 'identificationModule': {'nctId': 'NCT07228494', 'briefTitle': 'Comparative Study of Simulation Technologies for Use in Neonatal Resuscitation Training for Rural Hospitals', 'organization': {'class': 'OTHER', 'fullName': 'MaineHealth'}, 'officialTitle': 'Comparative Study of Simulation Technologies for Use in Neonatal Resuscitation Training for Rural Hospitals', 'orgStudyIdInfo': {'id': '2240996'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HoloBaby Arm', 'description': 'Participants in this arm will complete their simulations with the HoloBaby simulator technology', 'interventionNames': ['Other: HoloBaby Technology']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'High-fidelity Arm', 'description': 'Participants in this arm will complete their simulations with the traditional high-technology high-fidelity neonatal simulator', 'interventionNames': ['Other: High Fidelity Simulator Technology']}], 'interventions': [{'name': 'HoloBaby Technology', 'type': 'OTHER', 'description': 'The intervention will be utilizing HoloBaby technology for Neonatal Resuscitation Simulation Education.', 'armGroupLabels': ['HoloBaby Arm']}, {'name': 'High Fidelity Simulator Technology', 'type': 'OTHER', 'description': 'The intervention will be utilizing HiFi simulator technology for Neonatal Resuscitation Simulation Education.', 'armGroupLabels': ['High-fidelity Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04102', 'city': 'Portland', 'state': 'Maine', 'country': 'United States', 'contacts': [{'name': 'Leah Seften', 'role': 'CONTACT', 'email': 'leah.seften@mainehealth.org', 'phone': '207-662-6179'}, {'name': 'Misty Melendi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Mary Ottolini, MD, MEd', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'MaineHealth Maine Medical Center Portland', 'geoPoint': {'lat': 43.65737, 'lon': -70.2589}}], 'centralContacts': [{'name': 'Misty Melendi, MD', 'role': 'CONTACT', 'email': 'Misty.Melendi@MaineHealth.org', 'phone': '207-662-2553'}, {'name': 'Leah Marie Seften', 'role': 'CONTACT', 'email': 'leah.seften@mainehealth.org'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'data collected is team-based data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MaineHealth', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Chair of Neonatology', 'investigatorFullName': 'Misty Melendi', 'investigatorAffiliation': 'MaineHealth'}}}}