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

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.

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.

Inclusion Criteria:

• Gestational age 28-32 completed weeks, inclusive
• Placement of arterial line
• Successful initiation of nCPAP
• Informed Consent

Exclusion Criteria:

• Heart rate that cannot be stabilized >100 bpm within 5 minutes of birth
• Five (5) minute Apgar score ≤ 3
• Major congenital malformation(s) diagnosed antenatally or noted immediately after birth
• Other disease(s) or conditions potentially interfering with cardiopulmonary function
• Mother with prolonged rupture of membranes > 2 weeks
• Known or suspected chromosomal abnormality
• Need for chest compressions or administration of epinephrine, bicarbonate, or fluid boluses in the delivery room
• Need for mechanical ventilation within 30 minutes of birth