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Can a gentle air puff help preterm babies breathe and sleep better?

NCT ID NCT04584814

Symptom relief Sponsor: Pontificia Universidad Catolica de Chile 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 17, 2026 · Last updated Aug 27, 2026 · Updated 5 times

Summary

This pilot study is testing whether a device called a 'scare ventilator' can help preterm babies breathe more regularly and sleep better. Ten healthy preterm babies will be observed for two hours without the device, then for two hours with the device set at 20 air puffs per minute, and finally for two hours at 40 puffs per minute. Researchers will measure breathing, heart rate, oxygen levels, pain, and brain activity to see if the device helps.

What this could mean

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

Active substance
scare ventilator (a device that delivers gentle air puffs at set rates)
What this could lead to
If it works, this could point toward a non-drug way to help preterm babies breathe more steadily and sleep better.
What could go wrong
This is a very small pilot study (10 babies), so results may not apply broadly. The device might not improve breathing or could cause discomfort.

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

10 people

The number who actually took part.

Started

Mar 2020

Finished

Mar 2022

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

1 day 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: \- hospitalized healthy preterm babies, Exclusion Criteria: * babies receiving mechanical ventilation * carrier of any mayor malformation or genetic condition * sick or having an thorax or abdomen surgery

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Conditions

The condition(s) this trial relates to.

apnea of prematurity Obstetric Labor, Premature

As listed by the trial registrant

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

Apnea of newborn Preterm labor

Contacts and locations

Locations

  • Puc, Nicu

    Santiago, Santiago Metropolitan, 833-0024, Chile

More trials for these conditions

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