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Can a smarter breathing machine protect premature brains?

NCT ID NCT06786039

Knowledge-focused Sponsor: Korea University Anam Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 05, 2026 · Last updated Aug 06, 2026 · Updated 1 time

Summary

This study looks at whether a special breathing support called NIV-NAVA, which works with a baby's own breathing efforts, can improve outcomes for very premature infants. Researchers will follow about 80 babies born between 27 and 31 weeks of pregnancy who need breathing help soon after birth. They will track how often the support fails, lung problems, and long-term brain development to see if this approach offers benefits.

What this could mean

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

Active substance
Non-invasive neurally adjusted ventilatory assist (NIV-NAVA), a breathing support method that synchronizes with the infant's own breathing signals
What this could lead to
If this approach works well, it could lead to better breathing support strategies for very preterm infants, potentially reducing complications and improving long-term development.
What could go wrong
This is an observational study, so it cannot prove cause and effect. Results may be influenced by other factors, and the approach may not work for all infants.

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.

Participants

About 80 people

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

Started

Jan 2025

Expected to finish

Dec 2030

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.

Who is studied

Patients admitted to the NICU in Korea University Anam Hospital will be recruited over a 2-year period.

Ages

1 hour to 48 hours

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: * Preterm infants born between 27 weeks 0 days to 31 weeks 6 days of gestation * Preterm infants who require respiratory support within the first 48 hours of life Exclusion Criteria: * Preterm infants who die within the first 48 hours of life * Preterm infants who do not require any respiratory support within the first 48 hours of life. * Preterm infants with congenital anomalies affecting the lungs, heart, or other organs that could influence breathing * Infants whose parents do not consent to participate in the study

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Conditions

The condition(s) this trial relates to.

Premature Birth

As listed by the trial registrant

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

Preterm infant

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. 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

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Korea University Anam Hospital, NICU

    RECRUITING

    Seoul, Seoul, 02841, South Korea

  • Seoul National Bundang Hospital NICU

    NOT_YET_RECRUITING

    Seongnam-si, Gyeonggi-do, 13620, South Korea

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