A pilot study in premature infants who are born at less than 29 weeks to determine if surfactant given by aerosol is safe and well-tolerated.

AeroFact is an investigational drug/device combination product consisting of a naturally-derived surfactant (Aerosolized Alveofact®) of bovine origin administered via inhalation at a dosage of 108 mg/kg, with up to 4 doses administered over the first 72 hours of life. The AeroFact drug delivery system is designed to accurately and precisely administer aerosolized surfactant to the lungs of preterm infants who require supplemental oxygen and nasal continuous positive airway pressure (nCPAP) support via mechanical ventilation. The AeroFact drug delivery system consists of three commercially-available products, (1) Aerogen Solo/NIVO Nebulizer, (2) Aerogen Pro-X Controller, and (3) Sensirion Gas Flow Meter/Cable, which are connected to an investigational Aerogen Pharma Controller and investigational nCPAP prong interface. In Part I of the study, infants will receive a single aerosol dose of the study medication. Following initial aerosol dose to the lung, infants will continue on nCPAP. In Part II of the study, infants will receive an initial aerosol dose of the study medication. They will continue on nCPAP following the initial dose. Re-dosing of the study medication will occur if the Respiratory Severity Score to maintain oxygen saturation between 90 and 95% reaches 1.5 and at least six hours has elapsed since the previous dose. Up to three additional doses of study medication within 72 hours will be allowed.