ResuscitationNCT05551312
Mobile Virtual Simulation Training in Essential Newborn Care for Healthcare Workers in Low and Middle Income Countries
A study testing Virtual Essential Newborn Care (vENC) training in people with Resuscitation, run by University of Washington at 1 site in Nigeria.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Resuscitation
- What is being tested?
- Virtual Essential Newborn Care (vENC) training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteNigeria
- Study dates
- 1 Dec 2022to Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Must have a direct clinical role related to newborn care
- Is able and willing to attend and complete study-related engagements
Who cannot join
- Healthcare workers who have received essential newborn care course (ENCC) training within the past 12 months at time of recruitment
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Resuscitation
- Being tested
- Virtual Essential Newborn Care (vENC) training
- Keywords
- neonatal, resuscitation, education, virtual, simulation, mobile, phone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Essential Newborn Care (vENC) trainingOther
Essential Newborn Care Mobile Virtual Reality Simulation
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Virtual Essential Newborn Care (vENC) Training Receives: Other: Virtual Essential Newborn Care (vENC) training |
| Control | No intervention | Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with correct performance on essential newborn care objective structured clinical exam (OSCE) items at 6 months
Measured: at 6 months after in-person training
Early neonatal mortality
Defined as neonatal mortality within 7 days of birth
Measured: within 7 days of birth
Secondary outcomes (5)
Number of participants with correct performance on essential newborn care objective structured clinical exam (OSCE) items by 12 months
Measured: at 12 months after in-person training
Number of non-breathing newborns receiving bag and mask ventilation
Measured: 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
Measured: within 7 days of birth
Intrapartum-related mortality
Defined as intrapartum stillbirth (no breathing 10 minutes after delivery)
Measured: on day 1
Early neonatal mortality among babies requiring resuscitation
Defined as neonatal mortality within 7 days of birth among babies requiring resuscitation
Measured: within 7 days of birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start1 Dec 2022
- Primary completionFeb 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ResuscitationStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Lagos, Nigeria, eHealth4everyone
- Responsible party
- Principal investigator, Rachel Umoren, University of Washington
- Investigators
- Rachel Umoren, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05551312
- Sponsor's protocol ID
- STUDY00013179
- Other IDs
- 1R21HD107984
- Status last verified
- Jun 2023
- First submitted
- 18 Jul 2022
- Last updated
- 27 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Virtual Simulation Training in Essential Newborn Care for Healthcare Workers in Low and Middle Income Countries
- ClinicalTrials.gov ID
- NCT05551312
- Acronym / sponsor ID
- STUDY00013179
- Conditions
- Resuscitation
- Keywords
- neonatal, resuscitation, education, virtual, simulation, mobile, phone
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Lagos, Nigeria, eHealth4everyone
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 22 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Virtual Essential Newborn Care (vENC) trainingVirtual Essential Newborn Care (vENC) Training |
| Control | No intervention | –Standard of Care |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Must have a direct clinical role related to newborn care
- Is able and willing to attend and complete study-related engagements
Key exclusion criteria (1 listed)
- Healthcare workers who have received essential newborn care course (ENCC) training within the past 12 months at time of recruitment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Essential Newborn Care (vENC) trainingEssential Newborn Care Mobile Virtual Reality Simulation | Other | Intervention |
Primary outcome
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
Early neonatal mortality
Time frame: within 7 days of birth
Defined as neonatal mortality within 7 days of birth
5 secondary outcomes
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
Number of non-breathing newborns receiving bag and mask ventilation
Time frame: at delivery
Number of newborns receiving recommended essential newborn care practices
Time frame: within 7 days of birth
Intrapartum-related mortality
Time frame: on day 1
Early neonatal mortality among babies requiring resuscitation
Time frame: within 7 days of birth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel Umoren principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Essential Newborn Care (vENC) training in people with Resuscitation, run by University of Washington at 1 site in Nigeria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2023.