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

Neonatal Death Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05854745
• Other study ID #: 62973
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: January 2024

Study information

• Verified date: November 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 262
• Est. completion date: January 2024
• Est. primary completion date: August 19, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults

• Year IV through year VI medical students; year II through year IV nursing students; year II through year III midwifery students at Jimma University in Jimma, Ethiopia.

Exclusion Criteria:

• Minors

• Individuals who are not medical, nursing, 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.

Related Conditions & MeSH terms

• Asphyxia
• Asphyxia Neonatorum
• Birth Asphyxia
• Neonatal Death
• Perinatal Death

Intervention

Behavioral:
• HBB 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.
• HBB 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.

Locations

Country	Name	City	State
Ethiopia	Jimma University	Jimma

Sponsors (3)

Lead Sponsor	Collaborator
Stanford University	Jimma University, Laerdal Foundation

Country where clinical trial is conducted

Ethiopia, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Helping Babies Breathe Objective Structured Clinical Exam (OSCE) B	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.	Two months after HBB training (approximately 15 minutes to assess)
Secondary	Helping Babies Breathe Objective Structured Clinical Exam (OSCE) B	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.	Immediately after HBB training (approximately 15 minutes to assess)
Secondary	Helping Babies Breathe Objective Structured Clinical Exam (OSCE) A	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.	Two months after HBB training (approximately 10 minutes to assess)
Secondary	Helping Babies Breathe Objective Structured Clinical Exam (OSCE) A	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.	Immediately after HBB training (approximately 10 minutes to assess)
Secondary	Helping Babies Breathe Bag and Mask Ventilation score	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.	Immediately after HBB training (approximately 10 minutes to assess)
Secondary	Helping Babies Breathe Bag and Mask Ventilation score	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.	Two months after HBB training (approximately 10 minutes to assess)
Secondary	Helping Babies Breathe Multiple Choice Questionnaire score	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.	Immediately before HBB training (approximately 20 minutes to assess)
Secondary	Helping Babies Breathe Multiple Choice Questionnaire score	Determine knowledge acquisition 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.	Immediately after HBB training (approximately 20 minutes to assess)
Secondary	Helping Babies Breathe Multiple Choice Questionnaire score	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.	Two months after HBB training (approximately 20 minutes to assess)
Secondary	NeoNatalie Live Data: Heart rate	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.	Immediately after HBB training (approximately 10 minutes to assess)
Secondary	NeoNatalie Live Data: Ventilation pressure	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.	Immediately after HBB training (approximately 10 minutes to assess)
Secondary	NeoNatalie Live Data: Time to spontaneous breathing	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.	Immediately after HBB training (approximately 10 minutes to assess)
Secondary	NeoNatalie Live Data: Ventilation attempts	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.	Immediately after HBB training (approximately 10 minutes to assess)
Secondary	NeoNatalie Live Data: Heart rate	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.	Two months after HBB training (approximately 10 minutes to assess)
Secondary	NeoNatalie Live Data: Ventilation pressure	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.	Two months after HBB training (approximately 10 minutes to assess)
Secondary	NeoNatalie Live Data: Time to spontaneous breathing	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.	Two months after HBB training (approximately 10 minutes to assess)
Secondary	NeoNatalie Live Data: Ventilation attempts	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.	Two months after HBB training (approximately 10 minutes to assess)
Secondary	Attitude Questionnaire	5-point Likert scale designed to assess perceived confidence in performing HBB skills.	Immediately before HBB training (approximately 5 minutes to assess)
Secondary	Attitude Questionnaire	5-point Likert scale designed to assess perceived confidence in performing HBB skills as well as evaluation satisfaction with the course and its instructors.	Immediately after HBB training (approximately 5 minutes to assess)
Secondary	Attitude Questionnaire	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.	Two months after HBB training (approximately 5 minutes to assess)
Secondary	Profile of perceived barriers and facilitators	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.	Two months after HBB training (approximately 60 minutes to assess)