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Augmented Infant Resuscitator (AIR): Transitioning a Novel Behavior Change Innovation to Drive Newborn Ventilation Skills Enhancement

NCT05349175 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2025-11-20

No results posted yet for this study

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.

Conditions

  • Asphyxia Neonatorum
  • Birth Asphyxia
  • Perinatal Asphyxia

Interventions

DEVICE

Augmented Infant Resuscitator (AIR)

Real-time visual feedback from the AIR device regarding quality of bag-mask ventilation

Sponsors & Collaborators

  • United States Agency for International Development (USAID)

    collaborator FED

  • Grand Challenges Canada

    collaborator OTHER

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Brett D. Nelson, MD, MPH · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-02-01
Primary Completion
2024-06-30
Completion
2024-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05349175 on ClinicalTrials.gov