Augmented Infant Resuscitator to Enhance Newborn Ventilation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

270 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-01

Study Completion Date

2016-11-01

Brief Summary

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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.

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Detailed Description

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Longitudinal, randomized control trial that examined the effectiveness of AIR among 270 participants, with 1,080 recorded ventilation scenarios, and across 20 sites in Uganda and the U.S. Birth attendants - including a mix of midwives, nurses, respiratory therapists, pediatricians, and neonatologists - with recent HBB and/or NRP training were recruited to participate in this randomized control trial. Participants ventilated training mannequins for a fixed duration of time. Participants were randomized to receive visual feedback from AIR (intervention) or have the AIR feedback covered (control). They were then requested to administer effective ventilation and verbally assess the mannequin condition. All mannequins appeared to be identical, but each session's mannequin was randomly selected with an upper airway that was normal, partially leaking, or partially obstructed.

Conditions

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Asphyxia Neonatorum Birth Asphyxia Perinatal Asphyxia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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Blinded to visual feedback from AIR device

Providers did not receive AIR device feedback during newborn mannequin ventilation

Group Type PLACEBO_COMPARATOR

AIR device without feedback

Intervention Type DEVICE

Device provides no visual feedback to clinician but records data on ventilation effectiveness

Not blinded to visual feedback from AIR device

Providers did receive AIR device feedback during newborn mannequin ventilation

Group Type EXPERIMENTAL

Augmented Infant Resuscitator (AIR)

Intervention Type DEVICE

Device provides visual feedback related to air leak, obstruction, hyperventilation, hypoventilation, and harsh breaths

Interventions

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Augmented Infant Resuscitator (AIR)

Device provides visual feedback related to air leak, obstruction, hyperventilation, hypoventilation, and harsh breaths

Intervention Type DEVICE

AIR device without feedback

Device provides no visual feedback to clinician but records data on ventilation effectiveness

Intervention Type DEVICE

Other Intervention Names

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AIR device with feedback

Eligibility Criteria

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Inclusion Criteria

* Midwives, nurses, respiratory therapists, pediatricians, and neonatologists working as birth attendants in select hospitals in Uganda and the U.S. who are either previous trained in Helping Babies Breathe (HBB) and/or have a current Newborn Resuscitation Program (NRP) certification.