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

NCT ID: NCT05854745

Last Updated: 2024-11-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 262 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2023-10-23

Brief 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. 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.

Conditions

Neonatal Death; Birth Asphyxia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

HBB Virtual Training

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

HBB In-person Training

Intervention Type: 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.

Interventions

HBB Virtual 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.

Intervention Type: BEHAVIORAL

HBB In-person Training

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jimma University

OTHER

Sponsor Role: collaborator

Laerdal Foundation

OTHER

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Rishi Mediratta

Clinical Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rishi Mediratta

Role: STUDY_CHAIR

Stanford University

Locations

Jimma University

Jimma, , Ethiopia

Countries

Ethiopia

References

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.

Reference Type: BACKGROUND

PMID: 34104697 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31993430 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 39986344 (View on PubMed)

Other Identifiers

62973

Identifier Type: -

Identifier Source: org_study_id