NCT00807235

Feasibility Study of Aerosolized Surfaxin in the Prevention of Respiratory Distress Syndrome (RDS) in Premature Infants

An Open Label, Multicenter, Phase 2, Pilot Evaluation of SURFAXIN®(Lucinactant) Delivered as an Aerosol Via Nasal Continuous Positive Airway Pressure (nCPAP) in the Prevention of Respiratory Distress Syndrome in Premature Infants

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Windtree Therapeutics · Industry
• Sex: All
• Age: 15 Minutes – 30 Minutes
• Healthy volunteers: Not accepted

Summary

To evaluate the feasibility, safety and tolerability of aerosolized lucinactant delivered by nasal continuous positive airway pressure (nCPAP) for the prevention of respiratory distress syndrome (RDS) in premature infants.

Detailed description

Use of a device in the early treatment of RDS that permits the effective aerosolization of an exogenous surfactant that also allows for the simultaneous delivery of continuous positive airway pressure would permit the delivery of surfactant to the distal airways without intubation. This approach could reduce the frequency of severity of the adverse events relative to endotracheal intubation and surfactant administration via bolus.

Conditions

• Respiratory Distress Syndrome

Interventions

Type	Name	Description
DRUG	Aerosolized lucinactant	Aerosolized lucinactant via nCPAP over 3 hours. Up to 3 retreatments will be allowed over a 48 hour period with each retreatment separated by at least 3 hours.
DRUG	Aerosolized lucinactant	Aerosolized lucinactant via nCPAP over 3 hours. Up to 3 retreatments will be allowed over a 48 hour period with each retreatment separated by at least 1 hour.

Timeline

• Start date: 2005-01-01
• Primary completion: 2005-08-01
• Completion: 2005-09-01
• First posted: 2008-12-11
• Last updated: 2012-06-13
• Results posted: 2012-06-13

Locations

1 site across 1 country: United States