Respiratory distress syndrome (RDS), caused by surfactant deficiency, is the leading cause of
mortality and morbidity in preterm infants. Intratracheal instillation, the only approved
means of surfactant delivery, requires endotracheal intubation and mechanical ventilation
with their attendant risks. Interventions that decrease need for intubation and mechanical
ventilation like noninvasive ventilation (NIV) including nasal continuous positive airway
pressure, high flow nasal cannula or nasal intermittent mandatory ventilation are
increasingly being used for initial respiratory support in preterm neonates with RDS to
improve outcomes. Aerosolized surfactant delivered during NIV is an innovative and promising
concept for the treatment of RDS - retaining the advantages of early surfactant with alveolar
recruitment while obviating the risks of intubation and mechanical ventilation. The
investigators overall hypothesis is that treatment of RDS with aerosolized surfactant in
preterm infants undergoing NIV is safe and feasible and will result in short-term improvement
in oxygenation and ventilation. The objective of this proposal is to perform a single-center
unblinded Phase II randomized clinical trial of aerosolized surfactant for the treatment of
RDS in preterm neonates undergoing NIV. Funding Source - FDA-OOPD.