Mobile Virtual Simulation Training in Essential Newborn Care for Healthcare Workers in Low and Middle Income Countries

Resuscitation Clinical Trial

Official title:

Mobile Virtual Simulation Training in Essential Newborn Care for Healthcare Workers in Low and Middle Income Countries

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05551312
• Other study ID #: STUDY00013179
• Secondary ID: 1R21HD107984
• Status: Enrolling by invitation
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: August 2026

Study information

• Verified date: June 2023
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 150
• Est. completion date: August 2026
• Est. primary completion date: February 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Resuscitation

Intervention

Other:
• Virtual Essential Newborn Care (vENC) training
Essential Newborn Care Mobile Virtual Reality Simulation

Locations

Country	Name	City	State
Nigeria	University of Lagos	Lagos

Sponsors (4)

Lead Sponsor	Collaborator
University of Washington	eHealth4everyone, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Lagos, Nigeria

Country where clinical trial is conducted

Nigeria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Early neonatal mortality	Defined as neonatal mortality within 7 days of birth	within 7 days of birth
Secondary	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
Secondary	Number of non-breathing newborns receiving bag and mask ventilation		at delivery
Secondary	Number of newborns receiving recommended essential newborn care practices	WHO essential newborn care practices include skin to skin immediately after birth, cord care, early breastfeeding and vitamin K administration	within 7 days of birth
Secondary	Intrapartum-related mortality	Defined as intrapartum stillbirth (no breathing 10 minutes after delivery)	on day 1
Secondary	Early neonatal mortality among babies requiring resuscitation	Defined as neonatal mortality within 7 days of birth among babies requiring resuscitation	within 7 days of birth