- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05854745
Comparison of Virtual Training to In-Person Training of Helping Babies Breathe in Ethiopia
November 8, 2023 updated by: Rishi Mediratta, Stanford University
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
262
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Rishi Mediratta
- Phone Number: (650) 497-8000
- Email: rishimd@stanford.edu
Study Contact Backup
- Name: Melkamu Berhane
- Email: melkamuarefayine@gmail.com
Study Locations
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Jimma, Ethiopia
- Jimma University
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Contact:
- Melkamu Berhane
- Email: melkamuarefayine@gmail.com
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Virtual HBB Teaching
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.
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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.
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Active Comparator: In-person HBB Teaching
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Helping Babies Breathe Objective Structured Clinical Exam (OSCE) B
Time Frame: Two months after HBB training (approximately 15 minutes to assess)
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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.
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Two months after HBB training (approximately 15 minutes to assess)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Helping Babies Breathe Objective Structured Clinical Exam (OSCE) B
Time Frame: 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.
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Immediately after HBB training (approximately 15 minutes to assess)
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Helping Babies Breathe Objective Structured Clinical Exam (OSCE) A
Time Frame: Two months after HBB training (approximately 10 minutes to assess)
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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.
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Two months after HBB training (approximately 10 minutes to assess)
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Helping Babies Breathe Objective Structured Clinical Exam (OSCE) A
Time Frame: Immediately after HBB training (approximately 10 minutes to assess)
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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.
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Immediately after HBB training (approximately 10 minutes to assess)
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Helping Babies Breathe Bag and Mask Ventilation score
Time Frame: Immediately after HBB training (approximately 10 minutes to assess)
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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.
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Immediately after HBB training (approximately 10 minutes to assess)
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Helping Babies Breathe Bag and Mask Ventilation score
Time Frame: Two months after HBB training (approximately 10 minutes to assess)
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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.
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Two months after HBB training (approximately 10 minutes to assess)
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Helping Babies Breathe Multiple Choice Questionnaire score
Time Frame: Immediately before HBB training (approximately 20 minutes to assess)
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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.
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Immediately before HBB training (approximately 20 minutes to assess)
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Helping Babies Breathe Multiple Choice Questionnaire score
Time Frame: Immediately after HBB training (approximately 20 minutes to assess)
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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.
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Immediately after HBB training (approximately 20 minutes to assess)
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Helping Babies Breathe Multiple Choice Questionnaire score
Time Frame: Two months after HBB training (approximately 20 minutes to assess)
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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.
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Two months after HBB training (approximately 20 minutes to assess)
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NeoNatalie Live Data: Heart rate
Time Frame: Immediately after HBB training (approximately 10 minutes to assess)
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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.
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Immediately after HBB training (approximately 10 minutes to assess)
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NeoNatalie Live Data: Ventilation pressure
Time Frame: Immediately after HBB training (approximately 10 minutes to assess)
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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.
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Immediately after HBB training (approximately 10 minutes to assess)
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NeoNatalie Live Data: Time to spontaneous breathing
Time Frame: Immediately after HBB training (approximately 10 minutes to assess)
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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.
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Immediately after HBB training (approximately 10 minutes to assess)
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NeoNatalie Live Data: Ventilation attempts
Time Frame: Immediately after HBB training (approximately 10 minutes to assess)
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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.
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Immediately after HBB training (approximately 10 minutes to assess)
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NeoNatalie Live Data: Heart rate
Time Frame: Two months after HBB training (approximately 10 minutes to assess)
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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.
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Two months after HBB training (approximately 10 minutes to assess)
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NeoNatalie Live Data: Ventilation pressure
Time Frame: Two months after HBB training (approximately 10 minutes to assess)
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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.
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Two months after HBB training (approximately 10 minutes to assess)
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NeoNatalie Live Data: Time to spontaneous breathing
Time Frame: Two months after HBB training (approximately 10 minutes to assess)
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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.
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Two months after HBB training (approximately 10 minutes to assess)
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NeoNatalie Live Data: Ventilation attempts
Time Frame: Two months after HBB training (approximately 10 minutes to assess)
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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.
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Two months after HBB training (approximately 10 minutes to assess)
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Attitude Questionnaire
Time Frame: Immediately before HBB training (approximately 5 minutes to assess)
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5-point Likert scale designed to assess perceived confidence in performing HBB skills.
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Immediately before HBB training (approximately 5 minutes to assess)
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Attitude Questionnaire
Time Frame: Immediately after HBB training (approximately 5 minutes to assess)
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5-point Likert scale designed to assess perceived confidence in performing HBB skills as well as evaluation satisfaction with the course and its instructors.
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Immediately after HBB training (approximately 5 minutes to assess)
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Attitude Questionnaire
Time Frame: Two months after HBB training (approximately 5 minutes to assess)
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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.
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Two months after HBB training (approximately 5 minutes to assess)
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Profile of perceived barriers and facilitators
Time Frame: Two months after HBB training (approximately 60 minutes to assess)
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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.
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Two months after HBB training (approximately 60 minutes to assess)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Rishi Mediratta, Stanford University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2023
Primary Completion (Actual)
August 19, 2023
Study Completion (Estimated)
January 1, 2024
Study Registration Dates
First Submitted
April 27, 2023
First Submitted That Met QC Criteria
May 8, 2023
First Posted (Actual)
May 11, 2023
Study Record Updates
Last Update Posted (Estimated)
November 9, 2023
Last Update Submitted That Met QC Criteria
November 8, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 62973
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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