An interventional study of HBB Virtual Training and HBB In-person Training in Neonatal Death and Birth Asphyxia, sponsored by Stanford University. Completed at 1 site in Ethiopia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-22.
Sponsored by Stanford University · Not applicable, Interventional, and Health services research
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.
87 studies on the registry are indexed under Perinatal Death; 20 are open to participants now.
This study's enrollment of 262 is below the median of 500 across 59 interventional studies indexed under Perinatal Death.
Browse Perinatal Death studies →Stanford University is the lead sponsor of 2,162 studies on the registry; 429 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 207 (78%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Behavioral: HBB Virtual Training
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.
Behavioral: HBB In-person 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 (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) 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.
Time frame: Two months after HBB training (approximately 15 minutes to assess)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Two months after HBB training (approximately 60 minutes to assess)
Plan to share: Yes — Individual de-identified participant data and data dictionary will be available on Dryad within 12 months of publication.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Individual de-identified participant data and data dictionary will be available on Dryad within 12 months of publication.
Access criteria: Data will be shared with researchers upon reasonable request.
Ran from May 2023 to primary completion in Aug 2023, 3 months.
Of 27 interventional studies with no phase under Perinatal Death, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 54. This study's 3 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.