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| Name | Class |
|---|---|
| Jimma University | OTHER |
| Laerdal Foundation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HBB Virtual Training | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rishi Mediratta | Stanford University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jimma University | Jimma | Ethiopia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34104697 | Background | 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. | |
| 31993430 | Background | 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. |
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Individual de-identified participant data and data dictionary will be available on Dryad within 12 months of publication.
Individual de-identified participant data and data dictionary will be available on Dryad within 12 months of publication.
Data will be shared with researchers upon reasonable request.
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| ID | Term |
|---|---|
| D066087 | Perinatal Death |
| D001238 | Asphyxia Neonatorum |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003643 | Death |
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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.
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| HBB In-person Training | Behavioral | 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. |
|
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| Attitude Questionnaire | 5-point Likert scale designed to assess perceived confidence in performing HBB skills. | 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. | 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. | 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. | Two months after HBB training (approximately 60 minutes to assess) |
| 39986344 | Derived | Mediratta 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. |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |