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A Study in Preterm Neonates With Respiratory Distress Syndrome (RDS) Comparing CUROSURF® Administration Through Less Invasive Surfactant Administration (LISA) and Conventional Administration (LISPAP)
This study compared the administration of porcine surfactant (poractant alfa, Curosurf®) through a less invasive method (LISA), using a thin catheter, CHF 6440 (LISACATH®), during non-invasive ventilation (CPAP, NIPPV, BiPAP) with an approved conventional surfactant administration during invasive ventilation followed by rapid extubation in terms of short term and mid-term safety and efficacy in spontaneously breathing preterm neonates who have clinical signs of respiratory distress syndrome (RDS).
Details
| Lead sponsor | Chiesi Farmaceutici S.p.A. |
|---|---|
| Phase | PHASE3 |
| Status | TERMINATED |
| Enrolment | 33 |
| Start date | Tue May 18 2021 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Sat Aug 13 2022 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Respiratory Distress Syndrome (RDS)
Interventions
- LISA combination product (Curosurf+catheter CHF6440)
- Curosurf through conventional administration (endotracheal tube)
Countries
United States