Back to resultsComparison of Virtual Training to In-Person Training of Helping Babies Breathe in Ethiopia
Primary Purpose
Neonatal Death, Birth Asphyxia
Status
Not yet recruiting
Phase
Not Applicable
Locations
Ethiopia
Study Type
Interventional
Intervention
HBB Virtual Training
HBB In-person Training
Sponsored by
About this trial
This is an interventional health services research trial for Neonatal Death focused on measuring Helping Babies Breathe (HBB) training
Eligibility Criteria
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.
Sites / Locations
- Jimma University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Virtual HBB Teaching
In-person HBB Teaching
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Attitude Questionnaire
5-point Likert scale designed to assess perceived confidence in performing HBB skills.
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.
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.
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.
Full Information
NCT ID
NCT05854745
First Posted
April 27, 2023
Last Updated
May 8, 2023
Sponsor
Stanford University
Collaborators
Jimma University, Laerdal Foundation
1. Study Identification
Unique Protocol Identification Number
NCT05854745
Brief Title
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
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 2023 (Anticipated)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
Jimma University, Laerdal Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Death, Birth Asphyxia
Keywords
Helping Babies Breathe (HBB) training
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
320 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Virtual HBB Teaching
Arm Type
Experimental
Arm Description
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.
Arm Title
In-person HBB Teaching
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
HBB Virtual Training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
HBB In-person Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Helping Babies Breathe Objective Structured Clinical Exam (OSCE) B
Description
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.
Time Frame
Two months after HBB training (approximately 15 minutes to assess)
Secondary Outcome Measure Information:
Title
Helping Babies Breathe Objective Structured Clinical Exam (OSCE) B
Description
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.
Time Frame
Immediately after HBB training (approximately 15 minutes to assess)
Title
Helping Babies Breathe Objective Structured Clinical Exam (OSCE) A
Description
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.
Time Frame
Two months after HBB training (approximately 10 minutes to assess)
Title
Helping Babies Breathe Objective Structured Clinical Exam (OSCE) A
Description
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.
Time Frame
Immediately after HBB training (approximately 10 minutes to assess)
Title
Helping Babies Breathe Bag and Mask Ventilation score
Description
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.
Time Frame
Immediately after HBB training (approximately 10 minutes to assess)
Title
Helping Babies Breathe Bag and Mask Ventilation score
Description
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.
Time Frame
Two months after HBB training (approximately 10 minutes to assess)
Title
Helping Babies Breathe Multiple Choice Questionnaire score
Description
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.
Time Frame
Immediately before HBB training (approximately 20 minutes to assess)
Title
Helping Babies Breathe Multiple Choice Questionnaire score
Description
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.
Time Frame
Immediately after HBB training (approximately 20 minutes to assess)
Title
Helping Babies Breathe Multiple Choice Questionnaire score
Description
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.
Time Frame
Two months after HBB training (approximately 20 minutes to assess)
Title
NeoNatalie Live Data: Heart rate
Description
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.
Time Frame
Immediately after HBB training (approximately 10 minutes to assess)
Title
NeoNatalie Live Data: Ventilation pressure
Description
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.
Time Frame
Immediately after HBB training (approximately 10 minutes to assess)
Title
NeoNatalie Live Data: Time to spontaneous breathing
Description
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.
Time Frame
Immediately after HBB training (approximately 10 minutes to assess)
Title
NeoNatalie Live Data: Ventilation attempts
Description
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.
Time Frame
Immediately after HBB training (approximately 10 minutes to assess)
Title
NeoNatalie Live Data: Heart rate
Description
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.
Time Frame
Two months after HBB training (approximately 10 minutes to assess)
Title
NeoNatalie Live Data: Ventilation pressure
Description
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.
Time Frame
Two months after HBB training (approximately 10 minutes to assess)
Title
NeoNatalie Live Data: Time to spontaneous breathing
Description
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.
Time Frame
Two months after HBB training (approximately 10 minutes to assess)
Title
NeoNatalie Live Data: Ventilation attempts
Description
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.
Time Frame
Two months after HBB training (approximately 10 minutes to assess)
Title
Attitude Questionnaire
Description
5-point Likert scale designed to assess perceived confidence in performing HBB skills.
Time Frame
Immediately before HBB training (approximately 5 minutes to assess)
Title
Attitude Questionnaire
Description
5-point Likert scale designed to assess perceived confidence in performing HBB skills as well as evaluation satisfaction with the course and its instructors.
Time Frame
Immediately after HBB training (approximately 5 minutes to assess)
Title
Attitude Questionnaire
Description
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.
Time Frame
Two months after HBB training (approximately 5 minutes to assess)
Title
Profile of perceived barriers and facilitators
Description
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.
Time Frame
Two months after HBB training (approximately 60 minutes to assess)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rishi Mediratta
Phone
(650) 497-8000
Email
rishimd@stanford.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Melkamu Berhane
Email
melkamuarefayine@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rishi Mediratta
Organizational Affiliation
Stanford University
Official's Role
Study Chair
Facility Information:
Facility Name
Jimma University
City
Jimma
Country
Ethiopia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melkamu Berhane
Email
melkamuarefayine@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34104697
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.
Results Reference
background
PubMed Identifier
31993430
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.
Results Reference
background
Learn more about this trial
Comparison of Virtual Training to In-Person Training of Helping Babies Breathe in Ethiopia
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