NCT03058666

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 477 (actual)
• Sponsor: ONY · Industry
• Sex: All
• Age: 1 Hour – 24 Hours
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Respiratory Distress Syndrome

Interventions

Type	Name	Description
DRUG	Aerosolized Calfactant	Aerosolization of Infasurf at 6ml/kg via the modified Solarys aerosol generator.
DEVICE	Solarys	Aerosolization of Infasurf at 6ml/kg via the modified Solarys aerosol generator.

Timeline

• Start date: 2017-03-29
• Primary completion: 2018-06-01
• Completion: 2018-07-31
• First posted: 2017-02-23
• Last updated: 2024-05-29
• Results posted: 2024-05-29

Locations

22 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study