NCT04889001|Unknown
Ventilation Knowledge and Skills Retention Using a Novel Tool, the Augmented Infant Resuscitator (AIR) Device as an Instant-feedback Tool
Sim-II
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Sim-II
Sponsor study identifier
interventional
400
0 countries
N/A
Study Start
October 1, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 30, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Babies born not breathing at birth require effective gentle ventilation to survive and avert organ damage if initial resuscitation steps such as drying, and stimulation are unsuccessful at facilitating breathing. Training of health workers to impart skills on ventilation is a way to prevent these adverse outcomes. Effective ventilation skills are typically acquired through training programs such as Helping Babies Breath (HBB). However, these ventilation skills quickly decay following training and current skills retention methods such as refresher courses are costly and there is a paucity of skilled human resources to effectively facilitate frequent HBB training courses. This raises the need to explore approaches that are independent of retraining for skills maintenance. The investigators hypothesize that simulation enhanced HBB training followed by self-administered ventilation practice (SAVP) sessions with the Augmented Infant Resuscitator (AIR) as an electronic coach will result into ventilation skills retention over 12 months. SAVP allows participants to maintain practice and training to enhance skills retention.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 30, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 30, 2021
Actual (reported)May 17, 2021
Actual (reported)October 1, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 30, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Ventilation skills
Retention of ventilation skills measured using Helping babies breathe Objective Structured Clinical Examinations (OSCE)
12 months from baseline, after the training program
Time to effective ventilation
Time in seconds to effective ventilation
12 months from baseline, after the training program
Duration of effective ventilation
Time in seconds for the duration of effective ventilation
12 months from baseline, after the training program
Before and after comparison- one arm study
Simulation enhanced HBB is a one-day course delivered using a format of Explain, Demonstrate and Facilitate practice. Compared to the standard HBB training, the simulation enhanced HBB course is designed with increased peer-to-peer feedback and scripted expert facilitator feedback at HBB practice exercises.
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Data Santorino, MD
Mbarara University of Science and Technology
First Submitted
April 30, 2021
First Posted
May 17, 2021
Study Start
October 1, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Primary Completion
December 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 30, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 17, 2021
Record last verified: 2021-05
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Source: ClinicalTrials.gov.
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