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NCT02772081 · ClinicalTrials.gov registry record · Phase 3
A Study in Preterm Neonates With Respiratory Distress Syndrome (RDS) Comparing CUROSURF® Administration Through Less Invasive Surfactant Administration (LISA) and Conventional Administration
A Phase 3 study, sponsored by Chiesi Farmaceutici S.p.A..
- Terminated
- Registry status
- Phase 3
- Development phase
- 33
- Enrollment target
NCT02772081: Clinical Trial Phase 3 study, sponsored by Chiesi Farmaceutici S.p.A..
NCT02772081 is a Phase 3 study that was terminated before completion, run by Chiesi Farmaceutici S.p.A.. The registered enrollment target is 33 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02772081, a Phase 3 study, was terminated before completion, sponsored by Chiesi Farmaceutici S.p.A..
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 33 participants
- Enrollment target
Study 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).
Primary Outcome
Extent of exposure to study treatment is summarized by treatment group. Number of participants who received 1, 2, or 3 doses of treatment. All neonates received the first administration of Curosurf® 200 mg/kg. In case of lack of efficacy or clinical deterioration, a second dose of Curosurf® 100 mg/kg was administered using the same technique as the first dose. Neonates could receive a third Curosurf® 100 mg/kg dose if needed, administered using a standard technique. Results are presented as the
Interventions
- COMBINATION_PRODUCT LISA combination product (Curosurf+catheter CHF6440)
- DRUG Curosurf through conventional administration (endotracheal tube)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2021-05-18 |
| Est. Completion | 2022-08-13 |
| Phase | Phase 3 |
Why NCT02772081 stopped before completion
NCT02772081 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which LISA combination product (Curosurf+catheter CHF6440) is the first listed.
NCT02772081 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02772081 about?
NCT02772081 is a clinical study titled "A Study in Preterm Neonates With Respiratory Distress Syndrome (RDS) Comparing CUROSURF® Administration Through Less Invasive Surfactant Administration (LISA) and Conventional Administration". 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 ve...
What is the current status of trial NCT02772081?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 33 participants. The study started on 2021-05-18. Estimated completion is 2022-08-13.
What interventions are being tested in trial NCT02772081?
The interventions under investigation include: LISA combination product (Curosurf+catheter CHF6440) (COMBINATION_PRODUCT), Curosurf through conventional administration (endotracheal tube) (DRUG).
Who is sponsoring clinical trial NCT02772081?
This trial is sponsored by Chiesi Farmaceutici S.p.A., which has 30 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02772081's enrollment target sits among peer trials
33 1907th of 2000 higher than 92 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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