Clinical trial NCT05551312: Mobile Virtual Simulation Training in Essential Newborn Care for Healthcare Workers in Low and Middle Income Countries
Official title: Mobile Virtual Simulation Training in Essential Newborn Care for Healthcare Workers in Low and Middle Income Countries
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Resuscitation
Keywords: neonatal
resuscitation
education
virtual
simulation
mobile
phone
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: University of Lagos, Nigeria
name: eHealth4everyone
First posted: 2022-09-22
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: 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:

Specific 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.

Specific 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.

Specific 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.

Eligibility criteria: Inclusion Criteria:

* Must have a direct clinical role related to newborn care
* Is able and willing to attend and complete study-related engagements

Exclusion Criteria:

* Healthcare workers who have received essential newborn care course (ENCC) training within the past 12 months at time of recruitment

Primary outcomes:
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
Secondary outcomes:
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
measure: Intrapartum-related mortality
timeFrame: on day 1
measure: Early neonatal mortality among babies requiring resuscitation
timeFrame: within 7 days of birth
Other outcomes:
Locations:
city: Lagos
country: Nigeria
facility: University of Lagos
Study officials:
affiliation: University of Washington
name: Rachel Umoren
role: PRINCIPAL_INVESTIGATOR
References: