Status:
COMPLETED
Augmented Infant Resuscitator (AIR): Transitioning a Novel Behavior Change Innovation to Drive Newborn Ventilation Skills Enhancement
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
United States Agency for International Development (USAID)
Grand Challenges Canada
Conditions:
Asphyxia Neonatorum
Birth Asphyxia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Augmented Infant Resuscitator (AIR) is an inexpensive add-on, compatible with nearly every existing bag-valve mask and many types of ventilation equipment. AIR monitors ventilation quality and provide...
Detailed Description
The investigators propose a randomized controlled trial to asses the impact, feasibility, and acceptability of real-time visual feedback from the AIR device. The study will begin by training and equip...
Eligibility Criteria
Inclusion
- Skilled birth attendants (SBAs) working clinically at the selected facilities (i.e., in-service providers)
- SBAs who participate in the HBB training offered by our group at the beginning of the study
- SBAs who demonstrate competence, after initial training, in key neonatal resuscitation skills and competencies (i.e., pass the BMV skills check and OSCE B)
- SBAs able to adequately understand the language in which the HBB training is offered (e.g., the investigators anticipate the trainings will be offered in English)
- SBAs over 18 years of age
- SBAs who provide written informed consent for participation in the study
Exclusion
- Students or clinicians still in training (i.e., pre-service providers)
- SBAs and other health workers who do not participate in initial HBB training
- SBAs that are unable to adequately understand the language in which the HBB training is offered
- SBAs under 18 years of age
- SBAs who do not provide written informed consent for participation in the study
Key Trial Info
Start Date :
February 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2024
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT05349175
Start Date
February 1 2023
End Date
June 30 2024
Last Update
November 20 2025
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114