RecruitingOBSERVATIONAL

Evaluating the Safety and Performance of the MiniLung Petite Kit in Neonatal and Pediatric Patients With Acute Respiratory and Cardiac Failure

Doctors are studying a new device called the MiniLung Petite Kit to help babies and young children who have severe breathing or heart failure. These children often need machines to help them breathe or circulate blood when their own bodies can’t cope. The MiniLung Petite Kit is a small system designed to act like artificial lungs and heart, providing vital support. This study aims to see if using this kit is safe and effective in these very vulnerable patients. They want to find out if it improves their oxygen levels, removes carbon dioxide, and helps stabilise their blood circulation within the first 24 hours of treatment compared to other treatments they might have had before. Essentially, it's about making sure this new kit can safely keep these tiny patients alive and stable when they are critically ill.

At a glance

Status

Recruiting

Sponsor

Xenios AG

Enrolment target

Start

12 Oct 2025

Estimated completion

01 Dec 2026

Extracorporeal Membrane Oxygenation Complication Neonatal Aspiration Pneumonia Acute Respiratory Failure Acute Lung Injury

What is this study about?

When newborn babies and young children become very, very ill with serious breathing or heart problems, their bodies sometimes can't get enough oxygen or remove waste gases like carbon dioxide on their own. This can be life-threatening. In these difficult situations, doctors sometimes use a special support system called ECMO (Extracorporeal Membrane Oxygenation). ECMO acts like an artificial lung and sometimes an artificial heart, taking over some of the work so the child's own organs can rest and heal.

This particular study is looking at a new, smaller version of this support system called the MiniLung Petite Kit. It's designed specifically for tiny patients, those weighing between about 4.5 pounds and 17.5 pounds. The main goal is to carefully observe how this new kit works in real-life situations. Doctors want to see if it's safe to use and if it effectively helps these children get the oxygen they need and stabilises their heart and blood circulation.

By carefully watching how children respond to the MiniLung Petite Kit, researchers hope to gather important information. This information will help them understand if the kit is a good and safe option for treating very sick babies and young children who are struggling with severe breathing and heart failure. The ultimate aim is to improve the care and outcomes for these vulnerable patients.

Key takeaways

The study assesses a new breathing and heart support kit for critically ill babies and young children.
It aims to see if the MiniLung Petite Kit is safe and helps improve oxygen levels and heart function.
Children weighing between 2 kg and 8 kg (approx. 4.5 to 17.5 pounds) are included.
This is an observational study, meaning researchers collect information while the kit is used as part of necessary medical care.
The study seeks to improve outcomes for very vulnerable patients with severe breathing or heart failure.

Who may be eligible?

This study is looking for very young children who are extremely unwell with serious breathing or heart problems and are expected to need a special breathing support machine called ECMO. They must weigh between 2 kg (about 4.5 pounds) and 8 kg (about 17.5 pounds).

Before taking part, a parent or legal guardian must give their permission by signing a consent form. This ensures everyone understands what the study involves.

However, some children won't be able to join. This includes babies born very early (before 34 weeks of pregnancy), or if they have a known allergy to a blood-thinning medicine called heparin, or if they can't be given blood thinners for other medical reasons. Also, children who have recently been part of another similar medical study or have already been in this particular study won't be eligible.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is my child very sick with breathing or heart failure?
Does my child weigh between 2 kg and 8 kg?
Has my child been born at or after 34 weeks of pregnancy?
Does my child have any known allergy to heparin or issues with blood thinners?
Has my child participated in a similar medical study recently?
Am I, as a parent or legal guardian, able to give informed consent?

Answer every question to see your result.

What does participation involve?

If your child takes part in this study, doctors will use the MiniLung Petite Kit as part of their treatment for severe breathing or heart failure. Your child will be carefully monitored throughout their time on the machine, and for the first 24 hours especially, doctors will be observing how well the kit is working to help their breathing and heart. This is an observational study, meaning the kit is used as part of their necessary medical care, and researchers will simply be collecting information about its safety and performance. There aren't extra study-specific visits or medication, beyond the standard care your child would receive. The focus is on gathering data while the kit is providing life support.

Potential risks and benefits

The potential benefit of participating is that your child would receive treatment with the MiniLung Petite Kit, which aims to provide life-saving support for severe breathing and heart problems. This kit is designed to improve oxygen levels and stabilise circulation. As with any serious medical treatment for critically ill children, there are potential risks, which your medical team will discuss with you. These risks are generally related to the medical condition itself and the use of life support machines. You have the right to withdraw your child from the study at any time without affecting their medical care.

Locations (2)

Universitätsklinkum Bonn
Verified postcode
Bonn, Germany· Recruiting
Universitätsklinikum Mannheim
Verified postcode
Mannheim, Germany· Recruiting

Common questions

What is ECMO?

ECMO stands for Extracorporeal Membrane Oxygenation. It's a special machine that acts like an artificial lung and sometimes an artificial heart, helping very sick people get enough oxygen and remove waste gases when their own organs can't.

What does 'neonatal and paediatric' mean?

'Neonatal' refers to newborn babies, usually up to 28 days old. 'Paediatric' refers to children, usually from birth up to 18 years old. This study focuses on newborns and young children up to 8 months old.

Is the MiniLung Petite Kit a new type of treatment?

Yes, it's a newer, smaller version of the ECMO support system, specifically designed for very small children and babies, which is being carefully observed to see how well it works.

Will my child get different care if they join the study?

No, your child will receive the necessary life support treatment if they meet the criteria. The study is about observing how the MiniLung Petite Kit performs as part of that care, not about changing the care itself.

What is 'acute respiratory and cardiac failure'?

This means a sudden and very serious problem where the lungs and/or heart are not working properly, making it difficult for the body to get enough oxygen or pump blood effectively.

How to find out more

Anja Derlet-Savoia

anja.derlet@freseniusmedicalcare.com +49 6172 268 6648 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.