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

Stopped early · Phase 3

Conditions studied: Respiratory Distress Syndrome (RDS)

In brief

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).

Key facts

Study ID

NCT02772081

Run by

Chiesi Farmaceutici S.p.A.

People needed

33

Starts

2021-05-18

Expected to finish

2022-08-13

Last updated by the study team

2023-11-07

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Written informed consent obtained by parents/legal representative (according to local regulation) prior to or after birth
• Preterm neonates of either sex aged ≥30 minutes and <24 hours, spontaneously breathing and stabilized on non-invasive ventilation (NIV).
• Gestational age of 25+0 weeks up to 28+6 completed weeks, except for the first 15 enrolled neonates in which the gestational age will be restricted to 27+0 weeks up to 28+6 weeks.
• Clinical course consistent with RDS.
• Fraction of inspired oxygen (FiO2) ≥0.30 to maintain preductal oxygen saturation (SpO2) between 88-95%.

You may not qualify if…

• Need for immediate endotracheal intubation for cardiopulmonary resuscitation or insufficient respiratory drive
• Use of nasal high frequency oscillatory ventilation (nHFOV) prior to study entry
• Use of surfactant prior to study entry and need for intratracheal administration of any other treatment (e.g. nitric oxide)
• Known genetic or chromosomal disorders, major congenital anomalies (congenital heart diseases, myelomeningocele etc)
• Mothers with prolonged rupture of the membranes (> 21 days duration)
• Presence of air leaks if identified and known prior to study entry
• Evidence of severe birth asphyxia (e.g. continued need for resuscitation at 10 minutes after birth, altered neurological state, or neonatal encephalopathy)
• Neonatal seizures prior to study entry
• Any condition that, in the opinion of the Investigator, would place the neonate at undue risk
• Participation in another clinical trial of any medicinal product, placebo, experimental medical device, or biological substance conducted under the provisions of a protocol on the same therapeutic target.

Where it is running

• Chiesi Clinical Trial Site 84029 — Little Rock, Arkansas, United States
• Chiesi Clinical Trial Site 84001 — Los Angeles, California, United States
• Chiesi Clinical Trial Site 84002 — Los Angeles, California, United States
• Chiesi Clinical Trial Site 84013 — Denver, Colorado, United States
• Chiesi Clinical Trial Site 84026 — New Britain, Connecticut, United States
• Chiesi Clinical Trial Site 84003 — Evanston, Illinois, United States
• Chiesi Clinical Trial Site 84021 — Peoria, Illinois, United States
• Chiesi Clinical Trial Site 84023 — Lexington, Kentucky, United States
• Chiesi Clinical Trial Site 84028 — Springfield, Massachusetts, United States
• Chiesi Clinical Trial Site 84005 — Worcester, Massachusetts, United States
• Chiesi Clinical Trial Site 84008 — Lansing, Michigan, United States
• Chiesi Clinical Trial Site 84004 — St Louis, Missouri, United States
• Chiesi Clinical Trial Site 84012 — Camden, New Jersey, United States
• Chiesi Clinical Trial Site 84024 — Manhasset, New York, United States
• Chiesi Clinical Trial Site 84019 — New Hyde Park, New York, United States
• Chiesi Clinical Trial Site 84009 — Valhalla, New York, United States
• Chiesi Clinical Trial Site 84027 — Greenville, North Carolina, United States
• Chiesi Clinical Trial Site 84010 — Wilmington, North Carolina, United States
• Chiesi Clinical Trial Site 84025 — Cincinnati, Ohio, United States
• Chiesi Clinical Trial Site 84017 — Oklahoma City, Oklahoma, United States
• Chiesi Clinical Trial Site 84020 — Hershey, Pennsylvania, United States
• Chiesi Clinical Trial Site 84007 — Nashville, Tennessee, United States
• Chiesi Clinical Trial Site 84011 — Lubbock, Texas, United States
• Chiesi Clinical Trial Site 84006 — Plano, Texas, United States
• Chiesi Clinical Trial Site 84022 — Temple, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.