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Can a simple gas help fragile newborns breathe easier?

NCT ID NCT07247240

Disease control Sponsor: Asan Medical Center 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether inhaled nitric oxide can help newborns with a hole in their diaphragm (congenital diaphragmatic hernia) who also have high blood pressure in their lungs. About 40 babies will receive the gas, and doctors will check if their oxygen levels improve within 30 minutes. The goal is to see if this treatment can stabilize breathing and reduce the need for more intensive support.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 40 people

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

Expected to start

Nov 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 14 days

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: * Bochdalek type congenital diaphragmatic hernia * Gestational age at 34 weeks or more and within 14 days after birth * Hypoxic respiratory failure and pulmonary hypertension Exclusion Criteria: * Combined congenital heart disease requiring neonatal intervention or surgery * Previous treatment of pulmonary vasodilators including inhaled nitric oxide * on ECMO treatment

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Conditions

The condition(s) this trial relates to.

congenital diaphragmatic hernia pulmonary hypertension

As listed by the trial registrant

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

Congenital diaphragmatic hernia Pulmonary hypertension

How to take part

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

  1. The places running it

    4 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

  • Asan Medical Center

    Seoul, Seoul, 05505, South Korea

  • Chonnam National University Hospital

    Gwangju, 44935, South Korea

  • Seoul National University Children's Hospital

    Seoul, 03080, South Korea

  • Severance Hospital

    Seoul, 03722, South Korea

More trials for these conditions

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