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NCT05349175 · ClinicalTrials.gov registry record · NA

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

A NA study of Birth Asphyxia and Asphyxia Neonatorum, sponsored by Massachusetts General Hospital.

Completed
Registry status
NA
Development phase
250
Enrollment target
1
Study location

NCT05349175: Completed NA study of Birth Asphyxia and Asphyxia Neonatorum, sponsored by Massachusetts General Hospital.

NCT05349175 is a NA study of Birth Asphyxia and Asphyxia Neonatorum that has completed, run by Massachusetts General Hospital. The registered enrollment target is 250 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05349175, a NA study of Birth Asphyxia and Asphyxia Neonatorum, has completed, sponsored by Massachusetts General Hospital.

COMPLETED
Registry status
NA
Development phase
250 participants
Enrollment target
1
Study location

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.

Primary Outcome

Duration of effective bag-mask ventilation by clinician during a 2-minute trial. This is measured internally from the AIR device. "Effective ventilation" is defined as having all three of the following conditions simultaneously: (1) Correct rate (30-60 breaths per minute); (2) Absence of significant leak (compliance \>4.0mL/cm H2O); and (3) Absence of a significant airway blockage (defined as compliance \<0.10 mL/cm H2O or resistance \>90 cmH2O/L/s). These measurements are determined by sensors

Interventions

  • DEVICE Augmented Infant Resuscitator (AIR)

Study Locations (1)

Massachusetts

  • Massachusetts General Hospital - Boston

Trial Details

FieldValue
Enrollment Target 250 participants
Start Date 2023-02-01
Est. Completion 2024-06-30
Phase NA
Massachusetts General Hospital

2,032 total trials

What the finished NCT05349175 record still lists

NCT05349175 is an interventional study that assigns participants to a tested intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (82% lower).

The record links to 3 conditions, with Birth Asphyxia appearing as the primary indexed condition, and to 1 intervention - of which Augmented Infant Resuscitator (AIR) is the first listed.

NCT05349175 reports a single indexed study location in Massachusetts.

Frequently Asked Questions

What is clinical trial NCT05349175 about?

NCT05349175 is a clinical study titled "Augmented Infant Resuscitator (AIR): Transitioning a Novel Behavior Change Innovation to Drive Newborn Ventilation Skills Enhancement". 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 ...

What is the current status of trial NCT05349175?

This trial is currently completed. It is a NA study. The enrollment target is 250 participants. The study started on 2023-02-01. Estimated completion is 2024-06-30.

What conditions does trial NCT05349175 study?

This clinical trial studies the following conditions: Birth Asphyxia, Asphyxia Neonatorum, Perinatal Asphyxia.

What interventions are being tested in trial NCT05349175?

The interventions under investigation include: Augmented Infant Resuscitator (AIR) (DEVICE).

Who is sponsoring clinical trial NCT05349175?

This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05349175 being conducted?

This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Birth Asphyxia

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05349175's enrollment target sits among peer trials

250 410th of 2000 higher than 1,567 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05349175, the US trial registry maintained by the National Library of Medicine. NCT05349175 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.