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Mini lung machine tested on tiniest patients

NCT ID NCT06750536

Disease control Sponsor: Xenios AG 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing a small device called the MiniLung petite kit, which helps oxygenate blood and remove carbon dioxide in newborns and children weighing 2 to 8 kilograms who have severe breathing or heart failure. The device works with a console to temporarily take over the work of the lungs and heart. Researchers want to see if it safely improves oxygen levels and stabilizes vital signs within 24 hours. The study will enroll 20 participants and observe their progress.

What this could mean

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

Active substance
MiniLung petite kit (a miniaturized ECMO device used with the Xenios console)
What this could lead to
If successful, this could provide a safe and effective way to support breathing and heart function in very small infants with life-threatening respiratory or cardiac failure.
What could go wrong
This is a small, early observational study with only 20 participants, so results may not apply to all patients. ECMO itself carries risks like bleeding, infection, and blood clots.

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 20 people

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

Started

Oct 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Neonatal and/or pediatric patients with severe acute respiratory and/or cardiopulmonary failure treated with VV or VA ECMO.

Ages

Up to 8 months

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 * Informed consent signed and dated by parents or legal representative and investigator/authorized physician * Patients ≥2- ≤8 kg bodyweight to be treated with the MiniLung petite kit * Acute severe respiratory and/or cardiopulmonary failure with an ECMO indication Exclusion criteria: * Participation in an interventional clinical study during the preceding 30 days that could interfere with the ECLS therapy * Previous participation in the same study * Prematurity (\<34 weeks gestational age) * Hypersensitivity to heparin or known history of heparin induced thrombocytopenia (HIT) * Impossibility of systemic anticoagulation

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Conditions

The condition(s) this trial relates to.

acute lung injury acute respiratory failure aspiration pneumonia heart failure neonatal aspiration syndrome

As listed by the trial registrant

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

Acute lung injury Acute respiratory failure Extracorporeal membrane oxygenation complication Neonatal aspiration pneumonia

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

  • Universitätsklinikum Mannheim

    RECRUITING

    Mannheim, 68167, Germany

  • Universitätsklinkum Bonn

    RECRUITING

    Bonn, North Rhine-Westphalia, 53127, Germany

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