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Enrolling by Invitation

NCT Number: NCT05551312

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.

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Key information

Conditions

Resuscitation

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Lagos

Lagos, Nigeria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual Essential Newborn Care (vENC) training

Other

Essential Newborn Care Mobile Virtual Reality Simulation

Primary outcomes

  1. Number of participants with correct performance on essential newborn care objective structured clinical exam (OSCE) items at 6 months

    Time frame: at 6 months after in-person training

  2. Early neonatal mortality

    Time frame: within 7 days of birth

    Defined as neonatal mortality within 7 days of birth

Secondary outcomes

  1. Number of participants with correct performance on essential newborn care objective structured clinical exam (OSCE) items by 12 months

    Time frame: at 12 months after in-person training

  2. Number of non-breathing newborns receiving bag and mask ventilation

    Time frame: at delivery

  3. Number of newborns receiving recommended essential newborn care practices

    Time frame: 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

    Time frame: on day 1

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

  5. Early neonatal mortality among babies requiring resuscitation

    Time frame: within 7 days of birth

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

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • University of Lagos, Nigeria
  • eHealth4everyone

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Sep 22, 2022
Registry last updated
Jun 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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