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New breathing method may protect preemie lungs

NCT ID NCT03736707

Disease control Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a special breathing machine called high-frequency oscillation ventilation (HFOV) works better than standard mechanical ventilation for very premature babies (born at 24 to 31 weeks) who have acute respiratory distress syndrome (ARDS). The goal is to see if HFOV can lower the chance of developing bronchopulmonary dysplasia (BPD), a chronic lung disease common in preemies. About 400 babies will be randomly assigned to one of the two breathing methods, and researchers will track lung health and other outcomes.

What this could mean

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

Active substance
High-frequency oscillation ventilation (HFOV) device
What this could lead to
If this works, it could show that HFOV reduces lung damage and bronchopulmonary dysplasia in very preterm babies compared to standard ventilation.
What could go wrong
This is an early-stage trial with 400 infants, and results may not apply to all preterm babies. HFOV also carries risks like air leaks or bleeding in the brain.

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

About 400 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2025

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

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 minute to 1 hour

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 1. GA was between 24+0 and 31+6 weeks. 2. Preterm neonates were admitted to NICU within 1 hours after birth, diagnosed with perinatal ARDS using Montreux guidelines and stable supported by CMV. 3. Stabilization for 2 hours before randomization: FiO2 0.40, mean airway pressure (MAP) 10-14 cmH2O, ≤ 40 bpm of respiratory rate, 90%-94% of SpO2, pH \> 7.20, PaCO2 60 mmHg, tidal volume of 5 ml/kg and \> 35% of hematocrit (these may be evaluated by arterial blood gas analysis). Exclusion criteria Neonates were not included if any of the following criteria were met: 1. Parents or guardians' decision not to participate. 2. Major congenital anomalies or chromosomal abnormalities 3. Need for surgery or more than grade 2nd of IVH before randomization.

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Conditions

The condition(s) this trial relates to.

acute respiratory distress syndrome adult acute respiratory distress syndrome newborn respiratory distress syndrome Premature Birth

As listed by the trial registrant

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

Acute respiratory distress syndrome Conventional mechanical ventilation High frequency oscillatory ventilation Preterm

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Children's Hospital of Chongqing Medical University

    RECRUITING

    Chongqing, Chongqing Municipality, 400042, China

More trials for these conditions

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