Evaluating the Safety and Performance of the MiniLung Petite Kit in Neonatal and Pediatric Patients With Acute Respiratory and Cardiac Failure
Recruiting
Observational Study
Extracorporeal Membrane Oxygenation Complication
Neonatal Aspiration Pneumonia
Acute Respiratory Failure
Acute Lung Injury
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- Up to 8 Months
- Sex
- Any
- Study type
- Observational
- Participants needed
- 20 (estimated)
- Sponsor
- Xenios AG · Industry
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
About This Trial
This prospective observational study will evaluate the safety and performance of the MiniLung petite kit in neonatal and pediatric patients with acute respiratory and cardiac failure.
The main question it aims to answer is (study hypotheses):
Veno-venous (VV) and veno-arterial (VA) Extracorporeal Membrane Oxygenation (ECMO) using the MiniLung petite kit is safe and improves gas exchange (oxygena…
Trial Locations
Loading…
Loading trial locations…
Eligibility Criteria
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 cri…
Contacts