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Comparison of Virtual Training to In-Person Training of Helping Babies Breathe in Ethiopia

Comparison of Virtual Training to In-Person Training of Helping Babies Breathe in Ethiopia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05854745
Enrollment
262
Registered
2023-05-11
Start date
2023-05-01
Completion date
2023-10-23
Last updated
2024-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Birth Asphyxia, Neonatal Death

Keywords

Helping Babies Breathe (HBB) training

Brief summary

Helping Babies Breathe (HBB) is a program that teaches providers in low- and middle-income countries about neonatal resuscitation. Historically, HBB training was delivered in person. During the COVID-19 pandemic, many subject matter experts were unable to travel to conduct HBB courses. Innovative methods for teaching HBB are needed to promote the acquisition and retention of resuscitation skills and knowledge.

Detailed description

In this non-inferiority randomized controlled trial, medical students, nursing students, and midwifery students will be randomized to receive either standard in-person HBB training (control) or virtual telesimulation training (intervention). The hypothesis is that virtual delivery is as effective as in-person training of HBB content when teaching neonatal resuscitation skills and knowledge to medical, nursing, and midwifery students.

Interventions

BEHAVIORALHBB Virtual Training

HBB Virtual Training (Intervention): The 2nd edition HBB training course focuses on preparation for birth, routine care for all babies, the Golden Minute, and continued ventilation with normal or slow heart rate. The one-day virtual training will be delivered remotely to participants via Zoom. Facilitators and training materials will be the same in both the control and intervention arms.

BEHAVIORALHBB In-person Training

HBB In-Person Training (Control): The 2nd edition HBB training course focuses on preparation for birth, routine care for all babies, the Golden Minute, and continued ventilation with normal or slow heart rate. The one-day in-person training will be delivered in person. Facilitators and training materials will be the same in both the control and intervention arms.

Sponsors

Jimma University
CollaboratorOTHER
Laerdal Foundation
CollaboratorOTHER
Stanford University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

The content of each arm of the study is the same and will be taught live by the same HBB instructors; the only difference is the teaching method.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Adults * Year IV through year VI medical students, year II to IV nursing students, year II and III midwifery students at Jimma University in Jimma, Ethiopia.

Exclusion criteria

* Minors * Individuals who are not medical students, nursing students, or midwifery students at Jimma University. * Individuals who attended a neonatal resuscitation training course in the preceding year. * Individuals who would be unavailable or unwilling to participate in follow-up study activities throughout the 2-month post-initial training period.

Design outcomes

Primary

MeasureTime frameDescription
Helping Babies Breathe Objective Structured Clinical Exam (OSCE) BTwo months after HBB training (approximately 15 minutes to assess)Compare skill retention between the virtual delivery of Helping Babies Breathe (HBB) with the in-person delivery of HBB. This is a standardized evaluation of HBB skills, a score of 17 out of 23 is required to pass. Score range: 0 to 23, higher scores indicate better HBB skills, and a score of 17 or higher is required to pass.

Secondary

MeasureTime frameDescription
Helping Babies Breathe Objective Structured Clinical Exam (OSCE) ATwo months after HBB training (approximately 10 minutes to assess)Compare skill retention between the virtual delivery of Helping Babies Breathe (HBB) with the in-person delivery of HBB. This is a standardized evaluation of HBB skills, a score of 9 out of 12 is required to pass. Score range: 0 to 12, higher scores indicate better HBB skills, and a score of 9 or higher is required to pass.
Helping Babies Breathe Bag and Mask Ventilation scoreImmediately after HBB training (approximately 10 minutes to assess)Compare skill acquisition between virtual delivery of Helping Babies Breathe (HBB) with the in-person delivery of HBB. This is a standardized evaluation of bag and mask ventilation, a score out of 14. Score range: 0 to 14, higher scores indicate better HBB skills, and a score of 14 is required to pass.
Helping Babies Breathe Multiple Choice Questionnaire scoreImmediately before HBB training (approximately 20 minutes to assess)Determine baseline understanding of HBB material for each participant. This exam contains 18 questions pertaining to HBB curriculum. Score range: 0 to 18, higher scores indicate better HBB knowledge, and a score of 15 or higher is required to pass.
NeoNatalie Live Data: Heart rateImmediately after HBB training (approximately 10 minutes to assess)NeoNatalie Live is a mannequin that will provide data on bag-mask ventilation proficiency. During each simulation, the heart rate of the mannequin will be collected per participant.
Helping Babies Breathe Objective Structured Clinical Exam (OSCE) BImmediately after HBB training (approximately 15 minutes to assess)Compare skill acquisition between the virtual delivery of Helping Babies Breathe (HBB) with the in-person delivery of HBB. This is a standardized evaluation of HBB skills, a score of 17 out of 23 is required to pass. Score range: 0 to 23, higher scores indicate better HBB skills, and a score of 17 or higher is required to pass.
NeoNatalie Live Data: Time to spontaneous breathingImmediately after HBB training (approximately 10 minutes to assess)NeoNatalie Live is a mannequin that will provide data on bag-mask ventilation proficiency. Data about the amount of time it takes to reach a ventilation rate of 40-60 breaths per minute will be collected per participant.
NeoNatalie Live Data: Ventilation attemptsImmediately after HBB training (approximately 10 minutes to assess)NeoNatalie Live is a mannequin that will provide data on bag-mask ventilation proficiency. Data about the number of ventilation attempts will be collected per participant.
Attitude QuestionnaireImmediately before HBB training (approximately 5 minutes to assess)5-point Likert scale designed to assess perceived confidence in performing HBB skills.
Profile of perceived barriers and facilitatorsTwo months after HBB training (approximately 60 minutes to assess)Focus group discussions will be intended to understand differences in perceived barriers/facilitators of training. This will explore confidence in performing HBB techniques and attitudes toward virtual and in-person delivery of content. The objective of the focus groups will be to identify key themes around participants' perspectives of the HBB training to provide context around the outcomes listed above.
NeoNatalie Live Data: Ventilation pressureImmediately after HBB training (approximately 10 minutes to assess)NeoNatalie Live is a mannequin that will provide data on bag-mask ventilation proficiency. During each simulation, the ventilation pressure of the mannequin will be collected per participant.

Countries

Ethiopia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026