clinical trial · NCT03058666
Comparison of Aerosol Delivery of Infasurf to Usual Care in Spontaneously Breathing RDS Patients
ONY·phase3·completed·n = 477
Respiratory Distress SyndromeAerosolized CalfactantSolarys
brief summary
Study to test the hypothesis that aerosolized Infasurf can decrease the need for intubation and instillation of liquid surfactant to the airway.
started
Mar 29, 2017
primary completion
Jun 1, 2018
completion
Jul 31, 2018
last updated
May 29, 2024
detailed description
Treatment will not be masked. The study objective is to document that aerosolized Infasurf is superior to "usual care" and provides for some patients effective surfactant therapy with less need for endotracheal intubation and instillation of a surfactant suspension into the airway. Two cohorts will be recruited: (a) patients who did not receive surfactant at birth who develop RDS in the first hours of life and (b) patients who received instillation of surfactant for RDS in the first hour of life, were extubated, and have continuing RDS.
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol