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PreProMISe: Prophylactic vs Rescue MIST in Preterm Infants
NCT06007547Phase 4
Key facts
- Status
- Recruiting
- Start
- Jan 2024
- Primary completion
- Dec 2025
- Countries
- 1
- Sponsor
- Endeavor Health
- Modality
- Recombinant Proteins and Enzymes
- Drugs
- Poractant alfa
- Conditions
- respiratory distress syndrome (RDS)
01
Overview
Phase 4, randomised, open-label trial of Poractant alfa in respiratory distress syndrome (RDS) (2 arms), sponsored by Endeavor Health. Primary endpoint: Endotracheal Intubation at 7 days. Started Jan 2024; status: recruiting.
02
Design
2 arms- Study design
- RandomizedOpen-label
Prophylactic MIST
Curosurf 200 mg/kg via MIST within 15 mins of delivery.
Rescue MIST
Curosurf 200 mg/kg via MIST if FiO2 >= 30% in first 48h.
03
Who it enrols
Inborn preterm infants 22 0/7-29 6/7 weeks' gestation. Excludes infants with congenital anomalies or alternative causes for respiratory distress. Infants requiring emergent intubation in the delivery room are excluded from the intervention but outcomes are assessed.
04
Endpoints
Primary
Endotracheal Intubation
Secondary
Composite outcome of death or physiological bronchopulmonary dysplasia
Duration of mechanical respiratory support, CPAP, HFNC, oxygen therapy
Incidence of non-respiratory neonatal morbidities
Length of hospital stay
2-year developmental clinic visit data
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