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

• Sponsor: University of Washington (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05551312
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH), University of Lagos, Nigeria (Other), eHealth4everyone (Other)
• Enrollment: 150
• Arms: 2
• Anticipated Duration (Months): 47

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Resuscitation	Other: Virtual Essential Newborn Care (vENC) training	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Health Services Research
• Official Title: Mobile Virtual Simulation Training in Essential Newborn Care for Healthcare Workers in Low and Middle Income Countries
• Anticipated Study Start Date: Sep 1, 2022
• Anticipated Primary Completion Date: Feb 1, 2026
• Anticipated Study Completion Date: Aug 1, 2026

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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]

2. Early neonatal mortality [within 7 days of birth]

   Defined as neonatal mortality within 7 days of birth

Secondary Outcome Measures

1. 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]

2. Number of non-breathing newborns receiving bag and mask ventilation [at delivery]

3. Number of newborns receiving recommended essential newborn care practices [within 7 days of birth]

   WHO essential newborn care practices include skin to skin immediately after birth, cord care, early breastfeeding and vitamin K administration

4. Intrapartum-related mortality [on day 1]

   Defined as intrapartum stillbirth (no breathing 10 minutes after delivery)

5. Early neonatal mortality among babies requiring resuscitation [within 7 days of birth]

   Defined as neonatal mortality within 7 days of birth among babies requiring resuscitation

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Washington
• 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rachel Umoren, Assistant Professor, School of Medicine, University of Washington
• ClinicalTrials.gov Identifier: NCT05551312
• Other Study ID Numbers: STUDY00013179; 1R21HD107984
• First Posted: Sep 22, 2022
• Last Update Posted: Sep 22, 2022
• Last Verified: Sep 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Rachel Umoren, Assistant Professor, School of Medicine, University of Washington: neonatal; resuscitation; education; virtual; simulation; mobile; phone

Study Results

No Results Posted as of Sep 22, 2022