Trials / Recruiting
RecruitingNCT06750536
Evaluating the Safety and Performance of the MiniLung Petite Kit in Neonatal and Pediatric Patients With Acute Respiratory and Cardiac Failure
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 20 (estimated)
- Sponsor
- Xenios AG · Industry
- Sex
- All
- Age
- 8 Months
- Healthy volunteers
- Not accepted
Summary
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 (oxygenation and CO2 removal) and hemodynamic stabilization in neonatal and pediatric patients with severe acute respiratory and/or cardiopulmonary failure within 24 hours compared to the treatment before VV or VA ECMO initiation and maintain a life-sustaining condition.
Conditions
- Extracorporeal Membrane Oxygenation Complication
- Neonatal Aspiration Pneumonia
- Acute Respiratory Failure
- Acute Lung Injury
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | MiniLung petite kit combined with the Xenios console | Veno-venous (VV) and veno-arterial (VA) Extracorporeal Membrane Oxygenation (ECMO) treatment will be performed using the MiniLung petite kit combined with the Xenios console according to their intended use and local standards/requirements. |
Timeline
- Start date
- 2025-10-12
- Primary completion
- 2026-10-01
- Completion
- 2026-12-01
- First posted
- 2024-12-27
- Last updated
- 2025-12-24
Locations
2 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT06750536. Inclusion in this directory is not an endorsement.