Clinical trial NCT05854745: Comparison of Virtual Training to In-Person Training of Helping Babies Breathe in Ethiopia
Official title: Comparison of Virtual Training to In-Person Training of Helping Babies Breathe in Ethiopia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neonatal Death
Birth Asphyxia
Keywords: Helping Babies Breathe (HBB) training
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Jimma University
name: Laerdal Foundation
First posted: 2023-05-11
Enrollment: 262
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Helping Babies Breathe Objective Structured Clinical Exam (OSCE) B
timeFrame: Two months after HBB training (approximately 15 minutes to assess)
Secondary outcomes:
measure: Helping Babies Breathe Objective Structured Clinical Exam (OSCE) B
timeFrame: Immediately after HBB training (approximately 15 minutes to assess)
measure: Helping Babies Breathe Objective Structured Clinical Exam (OSCE) A
timeFrame: Two months after HBB training (approximately 10 minutes to assess)
measure: Helping Babies Breathe Objective Structured Clinical Exam (OSCE) A
timeFrame: Immediately after HBB training (approximately 10 minutes to assess)
measure: Helping Babies Breathe Bag and Mask Ventilation score
timeFrame: Immediately after HBB training (approximately 10 minutes to assess)
measure: Helping Babies Breathe Bag and Mask Ventilation score
timeFrame: Two months after HBB training (approximately 10 minutes to assess)
measure: Helping Babies Breathe Multiple Choice Questionnaire score
timeFrame: Immediately before HBB training (approximately 20 minutes to assess)
measure: Helping Babies Breathe Multiple Choice Questionnaire score
timeFrame: Immediately after HBB training (approximately 20 minutes to assess)
measure: Helping Babies Breathe Multiple Choice Questionnaire score
timeFrame: Two months after HBB training (approximately 20 minutes to assess)
measure: NeoNatalie Live Data: Heart rate
timeFrame: Immediately after HBB training (approximately 10 minutes to assess)
measure: NeoNatalie Live Data: Ventilation pressure
timeFrame: Immediately after HBB training (approximately 10 minutes to assess)
measure: NeoNatalie Live Data: Time to spontaneous breathing
timeFrame: Immediately after HBB training (approximately 10 minutes to assess)
measure: NeoNatalie Live Data: Ventilation attempts
timeFrame: Immediately after HBB training (approximately 10 minutes to assess)
measure: NeoNatalie Live Data: Heart rate
timeFrame: Two months after HBB training (approximately 10 minutes to assess)
measure: NeoNatalie Live Data: Ventilation pressure
timeFrame: Two months after HBB training (approximately 10 minutes to assess)
measure: NeoNatalie Live Data: Time to spontaneous breathing
timeFrame: Two months after HBB training (approximately 10 minutes to assess)
measure: NeoNatalie Live Data: Ventilation attempts
timeFrame: Two months after HBB training (approximately 10 minutes to assess)
measure: Attitude Questionnaire
timeFrame: Immediately before HBB training (approximately 5 minutes to assess)
measure: Attitude Questionnaire
timeFrame: Immediately after HBB training (approximately 5 minutes to assess)
measure: Attitude Questionnaire
timeFrame: Two months after HBB training (approximately 5 minutes to assess)
measure: Profile of perceived barriers and facilitators
timeFrame: Two months after HBB training (approximately 60 minutes to assess)
Other outcomes:
Locations:
city: Jimma
country: Ethiopia
facility: Jimma University
Study officials:
affiliation: Stanford University
name: Rishi Mediratta
role: STUDY_CHAIR
References:
citation: Sobelman C, Richard K, McQuilkin P, Fahey N. Adapting Helping Babies Breathe into a Virtual Curriculum: Methods, Results, and Lessons Learned. Glob Pediatr Health. 2021 May 31;8:2333794X211019698. doi: 10.1177/2333794X211019698. eCollection 2021.
citation: Jones-Bamman C, Niermeyer S, McConnell K, Thomas JF, Olson C. Teaching Helping Babies Breathe via Telehealth: A New Application in Rural Guatemala. Biomed Hub. 2019 Sep 24;4(3):1-6. doi: 10.1159/000502934. eCollection 2019 Sep-Dec.