Augmented Infant Resuscitator (AIR): Transitioning a Novel Behavior Change Innovation to Drive Ne… (NCT05349175) | Clinical Trial Compass
CompletedNot Applicable
Augmented Infant Resuscitator (AIR): Transitioning a Novel Behavior Change Innovation to Drive Newborn Ventilation Skills Enhancement
United States250 participantsStarted 2023-02-01
Plain-language 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 provides real-time objective feedback and actionable cues to clinicians to both shorten training times and improve resuscitation quality, adoption, retention, and confidence.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Effective bag-mask ventilation
Timeframe: 2 minutes
2
Time to effective bag-mask ventilation
Timeframe: 2 minutes
3
Bag-mask ventilation skills immediately after training