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Niftisurf: Calfactant vs Poractant alfa via MIST for RDS
NCT06074380Phase 4
Key facts
- Status
- Recruiting
- Start
- Jan 2024
- Primary completion
- Dec 2025
- Countries
- 1
- Sponsor
- Endeavor Health
- Modality
- Recombinant Proteins and Enzymes
- Conditions
- respiratory distress syndrome (RDS)
01
Overview
Phase 4, randomised, open-label trial in respiratory distress syndrome (RDS) comparing Calfactant with Poractant alfa (2 arms). Primary endpoint: Number of infants requiring Endotracheal Intubation at 7 days. Started Jan 2024; status: recruiting.
02
Design
2 arms- Study design
- RandomizedOpen-label
Calfactant
Calfactant (Infasurf) 3ml/kg via MIST
Poractant alfa
Poractant alfa (Curosurf) 2.5ml/kg via MIST
03
Who it enrols
Preterm infants 28-35 6/7 weeks' gestation and less than 48 hours of age with a clinical diagnosis of respiratory distress syndrome on NCPAP and FiO2 >= 0.30.
04
Endpoints
Primary
Number of infants requiring Endotracheal Intubation
Secondary
Duration of positive pressure support
Duration of Supplemental oxygen
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