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Breathing in sync: can timing ventilation to a Preemie's own breaths prevent dangerous oxygen dips?

NCT ID NCT03289936

Symptom relief Sponsor: University of Turin, Italy Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 15, 2026 · Last updated Sep 16, 2026 · Updated 1 time

Summary

Researchers compare two ways of giving nasal breathing support to preterm infants born before 32 weeks of pregnancy. One method delivers puffs of air on a fixed rhythm, while the other syncs each puff to the baby's own breathing using a flow sensor. The trial tracks how often babies experience low oxygen, pauses in breathing, and slow heart rates during their first days on this support.

What this could mean

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

Active substance
nasal intermittent positive pressure ventilation, delivered with or without synchronization to the baby's own breathing
What this could lead to
If synchronized ventilation reduces breathing pauses and oxygen dips, it could become the preferred first-line breathing support for preterm infants.
What could go wrong
This is a small, short-term crossover study of 30 infants. It measures breathing events, not long-term outcomes like lung health or brain development, so any benefit may not translate into lasting clinical improvement.

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

30 people

The number who actually took part.

Started

Nov 2020

Finished

Dec 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

Up to 32 weeks

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Gestational age at birth \<32 weeks * First approach to NIV ventilation (primary or after extubation) * Parent's informed consent Exclusion Criteria: * Neurological (including IVH \> 2° grade) or surgical diseases * Sepsis (clinical or laboratory confirmed) * Chromosomal or genetic abnormalities * Major malformations and congenital anomalies * Cardiac problems (including hemodynamically significant PDA) * Contraindication to NIV (i.e. nasal trauma and gastrointestinal surgery within the previous 7 days).

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Conditions

The condition(s) this trial relates to.

Hyaline Membrane Disease newborn respiratory distress syndrome Premature Birth Respiratory Aspiration

As listed by the trial registrant

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

Newborn respiratory distress Preterm infant

Contacts and locations

Locations

  • Ospedale S.Anna di Torino

    Torino, (TO), 10126, Italy

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