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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Resuscitation
• Intervention / Treatment: Other: Virtual Essential Newborn Care (vENC) training

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.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Nigeria
  • Lagos, Nigeria
    • University of Lagos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Standard of Care
Experimental: Intervention; Virtual Essential Newborn Care (vENC) Training	Other: Virtual Essential Newborn Care (vENC) training; Essential Newborn Care Mobile Virtual Reality Simulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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
Intrapartum-related mortality	Defined as intrapartum stillbirth (no breathing 10 minutes after delivery)	on day 1
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

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); University of Lagos, Nigeria; eHealth4everyone
• Investigators: Principal Investigator: Rachel Umoren, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: July 18, 2022
• First Submitted That Met QC Criteria: September 20, 2022
• First Posted (Actual): September 22, 2022

Study Record Updates

• Last Update Posted (Actual): June 27, 2023
• Last Update Submitted That Met QC Criteria: June 25, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: simulation; education; virtual; neonatal; resuscitation; phone; mobile
• Other Study ID Numbers: STUDY00013179; 1R21HD107984 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No