A Study in Preterm Neonates With Respiratory Distress Syndrome (RDS) Comparing CUROSURF® Administration Through Less Invasive Surfactant Administration (LISA) and Conventional Administration
Public ClinicalTrials.gov record NCT02772081. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT02772081
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 33 participants
Conditions and interventions
Conditions
Interventions
- LISA combination product (Curosurf+catheter CHF6440) Combination Product
- Curosurf through conventional administration (endotracheal tube) Drug
Combination Product · Drug
Eligibility (public fields only)
- Age range
- 30 Minutes to 24 Hours
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 18, 2021 (Actual)
- Primary completion
- Aug 13, 2022 (Actual)
- Completion
- Aug 13, 2022 (Actual)
- Last update posted
- Nov 7, 2023
2021 – 2022
United States locations
- U.S. sites
- 26
- U.S. states
- 18
- U.S. cities
- 25
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Chiesi Clinical Trial Site 84029 | Little Rock | Arkansas | 72205 | — |
| Chiesi Clinical Trial Site 84001 | Los Angeles | California | 90033 | — |
| Chiesi Clinical Trial Site 84002 | Los Angeles | California | 90033 | — |
| Chiesi Clinical Trial Site 84013 | Denver | Colorado | 80204 | — |
| Chiesi Clinical Trial Site 84026 | New Britain | Connecticut | 06052 | — |
| Chiesi Clinical Trial Site 84003 | Evanston | Illinois | 60201 | — |
| Chiesi Clinical Trial Site 84021 | Peoria | Illinois | 61637 | — |
| Chiesi Clinical Trial Site 84023 | Lexington | Kentucky | 40506 | — |
| Chiesi Clinical Trial Site 84028 | Springfield | Massachusetts | 01199 | — |
| Chiesi Clinical Trial Site 84005 | Worcester | Massachusetts | 01605 | — |
| Chiesi Clinical Trial Site 84008 | Lansing | Michigan | 48912 | — |
| Chiesi Clinical Trial Site 84004 | St Louis | Missouri | 63104 | — |
| Chiesi Clinical Trial Site 84012 | Camden | New Jersey | 08103 | — |
| Chiesi Clinical Trial Site 84024 | Manhasset | New York | 11030 | — |
| Chiesi Clinical Trial Site 84019 | New Hyde Park | New York | 11040 | — |
| Chiesi Clinical Trial Site 84009 | Valhalla | New York | 10595 | — |
| Chiesi Clinical Trial Site 84027 | Greenville | North Carolina | 27858 | — |
| Chiesi Clinical Trial Site 84010 | Wilmington | North Carolina | 28401 | — |
| Chiesi Clinical Trial Site 84025 | Cincinnati | Ohio | 45229 | — |
| Chiesi Clinical Trial Site 84017 | Oklahoma City | Oklahoma | 73104 | — |
| Chiesi Clinical Trial Site 84020 | Hershey | Pennsylvania | 17033 | — |
| Chiesi Clinical Trial Site 84007 | Nashville | Tennessee | 37212 | — |
| Chiesi Clinical Trial Site 84011 | Lubbock | Texas | 79410 | — |
| Chiesi Clinical Trial Site 84006 | Plano | Texas | 75075 | — |
| Chiesi Clinical Trial Site 84022 | Temple | Texas | 76502 | — |
| Chiesi Clinical Trial Site 84015 | Charlottesville | Virginia | 22908 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02772081, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 7, 2023 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02772081 live on ClinicalTrials.gov.