NCT02772081

A Study in Preterm Neonates With Respiratory Distress Syndrome (RDS) Comparing CUROSURF® Administration Through Less Invasive Surfactant Administration (LISA) and Conventional Administration

An Open-Label, Multicenter, Randomized, Controlled Study in Spontaneously Breathing Preterm Neonates With Respiratory Distress Syndrome to Compare Two Procedures for Porcine Surfactant (Poractant Alfa, CUROSURF®) Administration: A Less Invasive Method (LISA) During Non-invasive Ventilation (NIV) and the Conventional Administration During Brief Invasive Ventilation.

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Chiesi Farmaceutici S.p.A. · Industry
• Sex: All
• Age: 30 Minutes – 24 Hours
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

This study was an open-label, multicentre, randomized, controlled study of spontaneously breathing neonates with RDS. Neonates were evaluated according to the selection criteria and then randomized to surfactant treatment via LISA or standard administration procedure. The enrolment was staggered: the gestational age was restricted to 27+0 weeks up to 28+6 weeks for the first 15 neonates. Provided no safety concerns were raised, the enrolment was planned to be extended to the whole population (i.e. 25+0 weeks up to 28+6 weeks). Enrolled neonates were evaluated in a main phase of the trial until discharge or 40 weeks post-menstrual age (PMA), whichever came first. Their clinical status and neurodevelopment was to be assessed at 24-month corrected age as a separate stand-alone visit. The Sponsor decided to terminate the study early, due to uncertain sufficient availability of the CHF 6440 catheter.

Conditions

• Respiratory Distress Syndrome (RDS)

Interventions

Type	Name	Description
COMBINATION_PRODUCT	LISA combination product (Curosurf+catheter CHF6440)	Curosurf administration through brief insertion of a thin catheter into the trachea
DRUG	Curosurf through conventional administration (endotracheal tube)	Curosurf through conventional administration (endotracheal tube), followed by rapid extubation

Timeline

• Start date: 2021-05-18
• Primary completion: 2022-08-13
• Completion: 2022-08-13
• First posted: 2016-05-13
• Last updated: 2023-11-07
• Results posted: 2023-11-03

Locations

26 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study