Mobile Virtual Simulation Training in Essential Newborn Care for Healthcare Workers in Low and Middle Income Countries
2 other identifiers
interventional
150
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 18, 2022
CompletedFirst Posted
Study publicly available on registry
September 22, 2022
CompletedStudy Start
First participant enrolled
December 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2026
CompletedJune 27, 2023
June 1, 2023
3.2 years
July 18, 2022
June 25, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of participants with correct performance on essential newborn care objective structured clinical exam (OSCE) items at 6 months
at 6 months after in-person training
Early neonatal mortality
Defined as neonatal mortality within 7 days of birth
within 7 days of birth
Secondary Outcomes (5)
Number of participants with correct performance on essential newborn care objective structured clinical exam (OSCE) items by 12 months
at 12 months after in-person training
Number of non-breathing newborns receiving bag and mask ventilation
at delivery
Number of newborns receiving recommended essential newborn care practices
within 7 days of birth
Intrapartum-related mortality
on day 1
Early neonatal mortality among babies requiring resuscitation
within 7 days of birth
Study Arms (2)
Intervention
EXPERIMENTALVirtual Essential Newborn Care (vENC) Training
Control
NO INTERVENTIONStandard of Care
Interventions
Essential Newborn Care Mobile Virtual Reality Simulation
Eligibility Criteria
You may qualify if:
- Must have a direct clinical role related to newborn care
- Is able and willing to attend and complete study-related engagements
You may not qualify if:
- Healthcare workers who have received essential newborn care course (ENCC) training within the past 12 months at time of recruitment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Washingtonlead
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)collaborator
- University of Lagos, Nigeriacollaborator
- eHealth4everyonecollaborator
Study Sites (1)
University of Lagos
Lagos, Nigeria
Study Officials
- PRINCIPAL INVESTIGATOR
Rachel Umoren
University of Washington
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor, School of Medicine
Study Record Dates
First Submitted
July 18, 2022
First Posted
September 22, 2022
Study Start
December 1, 2022
Primary Completion
February 1, 2026
Study Completion
August 1, 2026
Last Updated
June 27, 2023
Record last verified: 2023-06