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Gadget that coaches baby resuscitation could save lives

NCT ID NCT05349175

Knowledge-focused Sponsor: Massachusetts General Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tested a device called the Augmented Infant Resuscitator (AIR), which attaches to standard bag-mask ventilators used to help newborns breathe. It gives real-time visual feedback to clinicians on their ventilation technique. Researchers enrolled 250 birth attendants to see if the device improves their skills during training and up to 6 months later. The goal is to make resuscitation training faster and more effective, especially in low-resource settings.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Augmented Infant Resuscitator (AIR) device
What this could lead to
If successful, this device could help train birth attendants more effectively, potentially reducing birth asphyxia deaths in low-resource settings.
What could go wrong
This is a completed training study on manikins, not patients. Real-world effectiveness and impact on newborn outcomes remain unproven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

250 people

The number who actually took part.

Started

Feb 2023

Finished

Jun 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

perinatal asphyxia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Asphyxia neonatorum Birth asphyxia Perinatal asphyxia

Contacts and locations

Locations

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.