Aerosolized Survanta in Neonatal Respiratory Distress Syndrome: Phase I Study

Background: Respiratory distress syndrome (RDS) is the leading cause of mortality and morbidity in preterm infants (PTI). Intratracheal instillation, the only approved means of surfactant delivery, requires endotracheal intubation and mechanical ventilation with their attendant risks. Widespread use of non-invasive ventilation (NIV) for initial respiratory support of PTI not only averts the need for intubation and MV but also delays surfactant instillation. We hypothesized that treatment of RDS with aerosolized surfactant (AS) in PTI undergoing NIV is safe and feasible.

Methods: We initiated a Phase I study of AS in PTI

Results: Of 17 patients enrolled, 15 were African American and 8 males. Two extremely PTI exited the study for worsening respiratory distress after one dose of AS. Fifteen infants completed study intervention; two were weaned to room air after the 1^st dose of AS and 13 received 2 doses. Infants tolerated the aerosol treatment well. No significant adverse events were identified. Of 15 infants that completed the study, one required medical treatment for a patent ductus arteriosus; one received vasopressors, two were treated medically for necrotizing enterocolitis (NEC) and one was intubated at 19 days of age following a diagnosis of NEC. Majority of the 17 enrolled infants were discharged to home (n=15) without respiratory support (n=14) at a mean corrected GA of 35^5/7 weeks.

Conclusions: We have demonstrated the feasibility of administering AS to PTI; AS was well tolerated by infants and clinical caregivers.