drugset / Trial / NCT03058666

Comparison of Aerosol Delivery of Infasurf to Usual Care in Spontaneously Breathing RDS Patients

NCT03058666 ↗

Phase 3 Completed 477 enrolled ONY
RandomizedParallel-groupOpen-labelTreatment

Summary

Study to test the hypothesis that aerosolized Infasurf can decrease the need for intubation and instillation of liquid surfactant to the airway.

Timeline

Start
2017-03-29
Primary completion
2018-06-01
Completion
2018-07-31

Outcome

Met primary endpoint

paper The rates of intubation for surfactant instillation were 26% in the aerosol group and 50% in the usual care group (P < .0001). PMID 33060258 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Calfactant Protein / enzyme biologic 210 mg/kg Inhaled