Ignite Creation Date:
2025-12-26 @ 10:45 PM
Ignite Modification Date:
2025-12-26 @ 10:45 PM
Study NCT ID:
NCT05551312
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-06-27
First Post:
2022-07-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mobile Virtual Simulation Training in Essential Newborn Care for Healthcare Workers in Low and Middle Income Countries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-25', 'studyFirstSubmitDate': '2022-07-18', 'studyFirstSubmitQcDate': '2022-09-20', 'lastUpdatePostDateStruct': {'date': '2023-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with correct performance on essential newborn care objective structured clinical exam (OSCE) items at 6 months', 'timeFrame': 'at 6 months after in-person training'}, {'measure': 'Early neonatal mortality', 'timeFrame': 'within 7 days of birth', 'description': 'Defined as neonatal mortality within 7 days of birth'}], 'secondaryOutcomes': [{'measure': 'Number of participants with correct performance on essential newborn care objective structured clinical exam (OSCE) items by 12 months', 'timeFrame': 'at 12 months after in-person training'}, {'measure': 'Number of non-breathing newborns receiving bag and mask ventilation', 'timeFrame': 'at delivery'}, {'measure': 'Number of newborns receiving recommended essential newborn care practices', 'timeFrame': 'within 7 days of birth', 'description': 'WHO essential newborn care practices include skin to skin immediately after birth, cord care, early breastfeeding and vitamin K administration'}, {'measure': 'Intrapartum-related mortality', 'timeFrame': 'on day 1', 'description': 'Defined as intrapartum stillbirth (no breathing 10 minutes after delivery)'}, {'measure': 'Early neonatal mortality among babies requiring resuscitation', 'timeFrame': 'within 7 days of birth', 'description': 'Defined as neonatal mortality within 7 days of birth among babies requiring resuscitation'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['neonatal', 'resuscitation', 'education', 'virtual', 'simulation', 'mobile', 'phone'], 'conditions': ['Resuscitation']}, 'descriptionModule': {'briefSummary': 'Intrapartum asphyxia and prematurity are the leading causes of neonatal mortality in low and middle income countries. Neonatal resuscitation training reduces asphyxia-related newborn mortality and morbidity, but in the absence of continuing low-dose, high frequency practice, these initial gains rapidly decay. The investigators propose to develop and evaluate innovative mobile virtual simulations for refresher training on neonatal resuscitation and essential newborn care to support the retention of knowledge and skills among health care workers in low and middle income countries.', 'detailedDescription': 'The main goal of this study is to improve newborn mortality and morbidity by using affordable and accessible mobile virtual simulations to provide quality skills training and maintenance for healthcare workers in Low/Middle income countries (LMIC). The investigators hypothesize that mobile devices will provide a readily accessible, standardized alternative to in-person training to maintain skills. This study has the following Specific Aims:\n\nSpecific Aim 1: Co-develop and pilot test the usability and efficacy of mobile virtual simulations on early newborn care skills among healthcare workers who attend deliveries in community and health facility-based settings.\n\nSpecific Aim 2: Evaluate the impact of the mobile virtual essential newborn care (vENC) training on neonatal resuscitation and care educational indicators and performance outcomes among healthcare workers who provide newborn care in community and health facility-based settings.\n\nSpecific Aim 3: Evaluate the impact of virtual simulation refresher training on the rates of neonatal mortality in primary, secondary and tertiary healthcare facilities in Nigeria.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must have a direct clinical role related to newborn care\n* Is able and willing to attend and complete study-related engagements\n\nExclusion Criteria:\n\n* Healthcare workers who have received essential newborn care course (ENCC) training within the past 12 months at time of recruitment'}, 'identificationModule': {'nctId': 'NCT05551312', 'briefTitle': 'Mobile Virtual Simulation Training in Essential Newborn Care for Healthcare Workers in Low and Middle Income Countries', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Mobile Virtual Simulation Training in Essential Newborn Care for Healthcare Workers in Low and Middle Income Countries', 'orgStudyIdInfo': {'id': 'STUDY00013179'}, 'secondaryIdInfos': [{'id': '1R21HD107984', 'link': 'https://reporter.nih.gov/quickSearch/1R21HD107984', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Virtual Essential Newborn Care (vENC) Training', 'interventionNames': ['Other: Virtual Essential Newborn Care (vENC) training']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Standard of Care'}], 'interventions': [{'name': 'Virtual Essential Newborn Care (vENC) training', 'type': 'OTHER', 'description': 'Essential Newborn Care Mobile Virtual Reality Simulation', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lagos', 'country': 'Nigeria', 'facility': 'University of Lagos', 'geoPoint': {'lat': 6.45407, 'lon': 3.39467}}], 'overallOfficials': [{'name': 'Rachel Umoren', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}, {'name': 'University of Lagos, Nigeria', 'class': 'OTHER'}, {'name': 'eHealth4everyone', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, School of Medicine', 'investigatorFullName': 'Rachel Umoren', 'investigatorAffiliation': 'University of Washington'}}}}