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Completed

NCT Number: NCT05854745

Comparison of Virtual Training to In-Person Training of Helping Babies Breathe in Ethiopia

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.

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Key information

Conditions

Neonatal Death Asphyxia Neonatorum Birth Asphyxia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Death Female Urogenital Diseases and Pregnancy Complications Infant, Newborn, Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Perinatal Death Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jimma University

Jimma, Ethiopia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Helping Babies Breathe Objective Structured Clinical Exam (OSCE) A

    Time frame: Two months after HBB training (approximately 10 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 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.

  3. Helping Babies Breathe Objective Structured Clinical Exam (OSCE) A

    Time frame: Immediately after HBB training (approximately 10 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 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.

  4. Helping Babies Breathe Bag and Mask Ventilation score

    Time frame: Immediately after HBB training (approximately 10 minutes to assess)

    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.

  5. Helping Babies Breathe Bag and Mask Ventilation score

    Time frame: Two months after HBB training (approximately 10 minutes to assess)

    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.

  6. Helping Babies Breathe Multiple Choice Questionnaire score

    Time frame: Immediately before HBB training (approximately 20 minutes to assess)

    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.

  7. Helping Babies Breathe Multiple Choice Questionnaire score

    Time frame: Immediately after HBB training (approximately 20 minutes to assess)

    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.

  8. Helping Babies Breathe Multiple Choice Questionnaire score

    Time frame: Two months after HBB training (approximately 20 minutes to assess)

    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.

  9. NeoNatalie Live Data: Heart rate

    Time frame: Immediately after HBB training (approximately 10 minutes to assess)

    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.

  10. NeoNatalie Live Data: Ventilation pressure

    Time frame: Immediately after HBB training (approximately 10 minutes to assess)

    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.

  11. NeoNatalie Live Data: Time to spontaneous breathing

    Time frame: Immediately after HBB training (approximately 10 minutes to assess)

    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.

  12. NeoNatalie Live Data: Ventilation attempts

    Time frame: Immediately after HBB training (approximately 10 minutes to assess)

    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.

  13. NeoNatalie Live Data: Heart rate

    Time frame: Two months after HBB training (approximately 10 minutes to assess)

    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.

  14. NeoNatalie Live Data: Ventilation pressure

    Time frame: Two months after HBB training (approximately 10 minutes to assess)

    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.

  15. NeoNatalie Live Data: Time to spontaneous breathing

    Time frame: Two months after HBB training (approximately 10 minutes to assess)

    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.

  16. NeoNatalie Live Data: Ventilation attempts

    Time frame: Two months after HBB training (approximately 10 minutes to assess)

    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.

  17. Attitude Questionnaire

    Time frame: Immediately before HBB training (approximately 5 minutes to assess)

    5-point Likert scale designed to assess perceived confidence in performing HBB skills.

  18. Attitude Questionnaire

    Time frame: Immediately after HBB training (approximately 5 minutes to assess)

    5-point Likert scale designed to assess perceived confidence in performing HBB skills as well as evaluation satisfaction with the course and its instructors.

  19. Attitude Questionnaire

    Time frame: Two months after HBB training (approximately 5 minutes to assess)

    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.

  20. Profile of perceived barriers and facilitators

    Time frame: Two months after HBB training (approximately 60 minutes to assess)

    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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Jimma University
  • Laerdal Foundation

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 11, 2023
Registry last updated
Nov 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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