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NCT02452476 · ClinicalTrials.gov registry record · Phase 2
A Double Blind, Randomized, Controlled Study to Evaluate CHF 5633 (Synthetic Surfactant) and Poractant Alfa in Neonates With Respiratory Distress Syndrome (RDS) (POC)
A Phase 2 study, sponsored by Chiesi Farmaceutici S.p.A..
- Completed
- Registry status
- Phase 2
- Development phase
- 123
- Enrollment target
NCT02452476 is a Phase 2 study that has completed, run by Chiesi Farmaceutici S.p.A.. The registered enrollment target is 123 participants.
The verdict
NCT02452476, a Phase 2 study, has completed, sponsored by Chiesi Farmaceutici S.p.A..
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 123 participants
- Enrollment target
Study Summary
A multicenter, double blind, randomized, single dose, active-controlled study to investigate the efficacy and safety of synthetic surfactant (CHF 5633) in comparison to porcine surfactant (Poractant alfa, Curosurf ®) in the treatment of preterm neonates with respiratory distress syndrome. Main objectives of this study are to investigate the short term efficacy profile of CHF 5633 vs. porcine surfactant (Poractant Alfa, Curosurf®) in terms of reduced oxygen requirement and ventilatory support and to evaluate the mid-term efficacy profile in terms of reduced incidence of bronchopulmonary dysplasia (BPD) and mortality/BPD rate at 36 weeks post menstrual age (PMA), mortality rate at 28 days and 36 weeks PMA, RDS-associated mortality through 14 days of age and other major co-morbidities of prematurity. Inclusion criteria are: Written parental informed consent, inborn preterm neonates of either sex with a gestational age of 24+0 weeks up to 29+6 weeks, clinical course consistent with RDS, requirement of endotracheal surfactant administration within 24 hours from birth, fraction of inspired oxygen (FiO2) ≥0.30 for babies 24+0 to 26+6 weeks and FiO2 ≥0.35 for babies 27+0 to 29+6 weeks to maintain arterial oxygen saturation by pulse oximetry (SpO2) between 88-95%.
Interventions
- DRUG Poractant alfa
- DRUG CHF5633
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 123 participants |
| Start Date | 2016-01-21 |
| Est. Completion | 2018-05-24 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02452476
The ClinicalTrials.gov registry entry for NCT02452476 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 123 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 Poractant alfa is the first listed.
NCT02452476 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02452476 about?
NCT02452476 is a clinical study titled "A Double Blind, Randomized, Controlled Study to Evaluate CHF 5633 (Synthetic Surfactant) and Poractant Alfa in Neonates With Respiratory Distress Syndrome (RDS) (POC)". A multicenter, double blind, randomized, single dose, active-controlled study to investigate the efficacy and safety of synthetic surfactant (CHF 5633) in comparison to porcine surfactant (Poractant alfa, Curosurf ®) in the treatment of preterm neonates with respiratory distress syndrome. Main objec...
What is the current status of trial NCT02452476?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 123 participants. The study started on 2016-01-21. Estimated completion is 2018-05-24.
What interventions are being tested in trial NCT02452476?
The interventions under investigation include: Poractant alfa (DRUG), CHF5633 (DRUG).
Who is sponsoring clinical trial NCT02452476?
This trial is sponsored by Chiesi Farmaceutici S.p.A., which has 30 total clinical trials registered on ClinicalTrials.gov.
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