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

Not Applicable

Completed

• Conditions: Birth Asphyxia; Neonatal Death
• Interventions: Behavioral: HBB Virtual Training; Behavioral: HBB In-person Training

• Registration Number: NCT05854745
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study First Submitted: 2023-04-27
• Study Start: 2023-05-01
• Study First Submitted QC: 2023-05-08
• Study First Posted: 2023-05-11
• Primary Completion: 2023-08-19
• Study Completion: 2023-10-23
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-20
• Last Update Posted: 2024-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 262

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Virtual HBB Teaching	HBB Virtual Training	HBB Virtual Training (Intervention): Participants will receive a blend of virtual training and telesimulation delivered by pediatricians from Ethiopia. The intervention consists of one day of virtual lectures and didactics from the HBB curriculum and skill assessments using neonatal mannequins.
In-person HBB Teaching	HBB In-person Training	Participants will receive in-person HBB instruction by pediatricians from Ethiopia. The control consists of one day of HBB lectures and didactics and skill assessments using neonatal mannequins.

Primary Outcome Measures

Name	Time	Method
Helping Babies Breathe Objective Structured Clinical Exam (OSCE) B	Two 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 Outcome Measures

Name	Time	Method
NeoNatalie Live Data: Ventilation attempts	Two months 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.
Helping Babies Breathe Bag and Mask Ventilation score	Two months after HBB training (approximately 10 minutes to assess)	Compare skill retention 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.
NeoNatalie Live Data: Heart rate	Two months 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) B	Immediately 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: Ventilation pressure	Two months 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.
Attitude Questionnaire	Two months after HBB training (approximately 5 minutes to assess)	5-point Likert scale designed to assess sustained perceived confidence in performing HBB skills as well as evaluation satisfaction with the course and its instructors.
Helping Babies Breathe Objective Structured Clinical Exam (OSCE) A	Immediately after HBB training (approximately 10 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 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 Multiple Choice Questionnaire score	Two months after HBB training (approximately 20 minutes to assess)	Determine knowledge retention 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: Time to spontaneous breathing	Two months 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.
Profile of perceived barriers and facilitators	Two 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.

Trial Locations

Locations (1)

Jimma University; 🇪🇹 Jimma, Ethiopia