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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 is a Phase 3 study that was terminated before completion, run by Chiesi Farmaceutici S.p.A.. The registered enrollment target is 33 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02772081
The ClinicalTrials.gov registry entry for NCT02772081 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 33 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Chiesi Farmaceutici S.p.A., which has 30 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which LISA combination product (Curosurf+catheter CHF6440) is the first listed.
NCT02772081 reports 0 study locations.
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.
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