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

NCT05854745 | Completed

• 1 other identifier: 62973
• Study Type: interventional
• Target: 262
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonatal Death; Birth Asphyxia

Keywords

Helping Babies Breathe (HBB) training

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (20)

• Helping Babies Breathe Objective Structured Clinical Exam (OSCE) B

  Immediately after HBB training (approximately 15 minutes to assess)

• Helping Babies Breathe Objective Structured Clinical Exam (OSCE) A

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

• Helping Babies Breathe Objective Structured Clinical Exam (OSCE) A

  Immediately after HBB training (approximately 10 minutes to assess)

• Helping Babies Breathe Bag and Mask Ventilation score

  Immediately after HBB training (approximately 10 minutes to assess)

• Helping Babies Breathe Bag and Mask Ventilation score

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

Study Arms (2)

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.

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.

Behavioral: HBB In-person Training

Interventions

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.

Virtual HBB Teaching

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.

In-person HBB Teaching

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead
• Jimma University: collaborator
• Laerdal Foundation: collaborator

Study Sites (1)

Jimma University

Jimma, Ethiopia

Location

Related Publications (3)

• 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.

  PMID: 34104697 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.

  PMID: 31993430 BACKGROUND

• 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.

  PMID: 39986344 DERIVED

MeSH Terms

Conditions

Perinatal Death; Asphyxia Neonatorum

Condition Hierarchy (Ancestors)

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

Study Officials

• Rishi Mediratta

  Stanford University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: April 27, 2023
• First Posted: May 11, 2023
• Study Start: May 1, 2023
• Primary Completion: August 19, 2023
• Study Completion: October 23, 2023
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.

Locations

ET (1)