Neonatal DeathNCT05854745
Comparison of Virtual Training to In-Person Training of Helping Babies Breathe in Ethiopia
A study testing HBB Virtual Training and HBB In-person Training in people with Neonatal Death and Birth Asphyxia, run by Stanford University at 1 site in Ethiopia.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neonatal Death, Birth Asphyxia
- What is being tested?
- HBB Virtual Training and HBB In-person Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 262 participants
- Where
- 1 siteEthiopia
- Study dates
- 1 May 2023to 23 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Neonatal Death, Birth Asphyxia
- Being tested
- HBB Virtual Training, HBB In-person Training
- Keywords
- Helping Babies Breathe (HBB) training
- Medical subject headings
- Perinatal Death, Asphyxia Neonatorum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HBB Virtual TrainingBehavioural
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 TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Virtual HBB Teaching | Experimental | 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. Receives: Behavioral: HBB Virtual Training |
| In-person HBB Teaching | Active comparator | 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. Receives: Behavioral: HBB In-person Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Two months after HBB training (approximately 15 minutes to assess)
Secondary outcomes (20)
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.
Measured: Immediately after HBB training (approximately 15 minutes to assess)
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.
Measured: Two months after HBB training (approximately 10 minutes to assess)
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.
Measured: Immediately after HBB training (approximately 10 minutes to assess)
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.
Measured: Immediately after HBB training (approximately 10 minutes to assess)
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.
Measured: Two months after HBB training (approximately 10 minutes to assess)
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.
Measured: Immediately before HBB training (approximately 20 minutes to assess)
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.
Measured: Immediately after HBB training (approximately 20 minutes to assess)
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.
Measured: Two months after HBB training (approximately 20 minutes to assess)
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.
Measured: Immediately after HBB training (approximately 10 minutes to assess)
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.
Measured: Immediately after HBB training (approximately 10 minutes to assess)
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.
Measured: Immediately after HBB training (approximately 10 minutes to assess)
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.
Measured: Immediately after HBB training (approximately 10 minutes to assess)
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.
Measured: Two months after HBB training (approximately 10 minutes to assess)
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.
Measured: Two months after HBB training (approximately 10 minutes to assess)
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.
Measured: Two months after HBB training (approximately 10 minutes to assess)
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.
Measured: Two months after HBB training (approximately 10 minutes to assess)
Attitude Questionnaire
5-point Likert scale designed to assess perceived confidence in performing HBB skills.
Measured: Immediately before HBB training (approximately 5 minutes to assess)
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.
Measured: Immediately after HBB training (approximately 5 minutes to assess)
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.
Measured: Two months after HBB training (approximately 5 minutes to assess)
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.
Measured: Two months after HBB training (approximately 60 minutes to assess)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start1 May 2023
- Primary completion19 Aug 2023
- Study completion23 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Neonatal DeathStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Jimma University, Laerdal Foundation
- Responsible party
- Principal investigator, Rishi Mediratta, Stanford University
- Investigators
- Rishi Mediratta, Study chair, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05854745
- Sponsor's protocol ID
- 62973
- Status last verified
- Nov 2024
- First submitted
- 27 Apr 2023
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual de-identified participant data and data dictionary will be available on Dryad within 12 months of publication.
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.
PubMed 34104697Jones-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.
PubMed 31993430Mediratta RP, Clary MK, Liang JW, Daniels K, Muhe LM, Lee HC, Eshetu B, Berhane M. Remote versus in-person pre-service neonatal resuscitation training: A noninferiority randomized controlled trial in Ethiopia. Resuscitation. 2025 Apr;209:110556. doi: 10.1016/j.resuscitation.2025.110556. Epub 2025 Feb 20.
PubMed 39986344
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Virtual Training to In-Person Training of Helping Babies Breathe in Ethiopia
- ClinicalTrials.gov ID
- NCT05854745
- Acronym / sponsor ID
- 62973
- Conditions
- Neonatal Death, Birth Asphyxia
- Keywords
- Helping Babies Breathe (HBB) training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Jimma University, Laerdal Foundation
- Study start
- 1 May 2023 (actual)
- Primary completion
- 19 Aug 2023 (actual)
- Study completion
- 23 Oct 2023 (actual)
- First posted
- 11 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Virtual HBB Teaching | Experimental | Behavioral: HBB Virtual TrainingHBB 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 | Active comparator | Behavioral: HBB In-person TrainingParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HBB Virtual TrainingHBB 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. | Behavioural | Virtual HBB Teaching |
| HBB In-person TrainingHBB 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. | Behavioural | In-person HBB Teaching |
Primary outcome
Helping Babies Breathe Objective Structured Clinical Exam (OSCE) B
Time frame: 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.
20 secondary outcomes
Helping Babies Breathe Objective Structured Clinical Exam (OSCE) B
Time frame: Immediately after HBB training (approximately 15 minutes to assess)
Helping Babies Breathe Objective Structured Clinical Exam (OSCE) A
Time frame: Two months after HBB training (approximately 10 minutes to assess)
Helping Babies Breathe Objective Structured Clinical Exam (OSCE) A
Time frame: Immediately after HBB training (approximately 10 minutes to assess)
Helping Babies Breathe Bag and Mask Ventilation score
Time frame: Immediately after HBB training (approximately 10 minutes to assess)
Helping Babies Breathe Bag and Mask Ventilation score
Time frame: Two months after HBB training (approximately 10 minutes to assess)
Helping Babies Breathe Multiple Choice Questionnaire score
Time frame: Immediately before HBB training (approximately 20 minutes to assess)
Helping Babies Breathe Multiple Choice Questionnaire score
Time frame: Immediately after HBB training (approximately 20 minutes to assess)
Helping Babies Breathe Multiple Choice Questionnaire score
Time frame: Two months after HBB training (approximately 20 minutes to assess)
NeoNatalie Live Data: Heart rate
Time frame: Immediately after HBB training (approximately 10 minutes to assess)
NeoNatalie Live Data: Ventilation pressure
Time frame: Immediately after HBB training (approximately 10 minutes to assess)
NeoNatalie Live Data: Time to spontaneous breathing
Time frame: Immediately after HBB training (approximately 10 minutes to assess)
NeoNatalie Live Data: Ventilation attempts
Time frame: Immediately after HBB training (approximately 10 minutes to assess)
NeoNatalie Live Data: Heart rate
Time frame: Two months after HBB training (approximately 10 minutes to assess)
NeoNatalie Live Data: Ventilation pressure
Time frame: Two months after HBB training (approximately 10 minutes to assess)
NeoNatalie Live Data: Time to spontaneous breathing
Time frame: Two months after HBB training (approximately 10 minutes to assess)
NeoNatalie Live Data: Ventilation attempts
Time frame: Two months after HBB training (approximately 10 minutes to assess)
Attitude Questionnaire
Time frame: Immediately before HBB training (approximately 5 minutes to assess)
Attitude Questionnaire
Time frame: Immediately after HBB training (approximately 5 minutes to assess)
Attitude Questionnaire
Time frame: Two months after HBB training (approximately 5 minutes to assess)
Profile of perceived barriers and facilitators
Time frame: Two months after HBB training (approximately 60 minutes to assess)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Background: PubMed 34104697Sobelman 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.
- Background: PubMed 31993430Jones-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.
- Derived from this study: PubMed 39986344Mediratta RP, Clary MK, Liang JW, Daniels K, Muhe LM, Lee HC, Eshetu B, Berhane M. Remote versus in-person pre-service neonatal resuscitation training: A noninferiority randomized controlled trial in Ethiopia. Resuscitation. 2025 Apr;209:110556. doi: 10.1016/j.resuscitation.2025.110556. Epub 2025 Feb 20.
- Individual participant dataSharing planned: Yes. Individual de-identified participant data and data dictionary will be available on Dryad within 12 months of publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rishi Mediratta study chair
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HBB Virtual Training and HBB In-person Training in people with Neonatal Death and Birth Asphyxia, run by Stanford University at 1 site in Ethiopia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Helping Babies Breathe Objective Structured Clinical Exam (OSCE) B (time frame: Two months after HBB training (approximately 15 minutes to assess)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05854745, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2024.