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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)

NCT02772081 PHASE3 TERMINATED Results posted

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 sponsorChiesi Farmaceutici S.p.A.
PhasePHASE3
StatusTERMINATED
Enrolment33
Start dateTue May 18 2021 00:00:00 GMT+0000 (Coordinated Universal Time)
CompletionSat Aug 13 2022 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

Interventions

Countries

United States