An open label, pilot study of Aerosurf® combined with nCPAP to prevent RDS in preterm neonates

J Aerosol Med Pulm Drug Deliv. 2010 Oct;23(5):303-9. doi: 10.1089/jamp.2009.0758.


Background: Nasal continuous positive airway pressure (nCPAP) is an accepted mode of respiratory support for preterm infants with respiratory insufficiency. To avoid potential sequelae of endotracheal (ET) intubation and mechanical ventilation, prophylactic aerosolization of surfactant delivered via nCPAP has been attempted with limited success.

Methods: To determine the feasibility and safety of prophylactic aerosolization of a peptide-containing synthetic surfactant, Aerosurf® (lucinactant for inhalation) was delivered by nCPAP to preterm infants at risk for respiratory distress syndrome (RDS). Neonates were enrolled into treatment group 1 (Aerosurf retreatment separated by at least 3 h) or treatment group 2 (Aerosurf retreatment separated by at least 1 h). A vibrating membrane nebulizer Aeroneb Pro® was used to aerosolize 20 mg/mL Aerosurf. All neonates received the initial 3-h treatment, and three retreatments were permitted within 48 h based on clinical response.

Results: Seventeen infants were enrolled. Aerosurf was well tolerated, with transient desaturations observed during dosing without bradycardia or hypotension. Variability in output rates of the Aeroneb Pro was observed leading to different average dispensed drug volumes per treatment per patient. All infants survived; 29.4% required subsequent ET surfactant replacement therapy, 23.5% were diagnosed with RDS at 24 h, and 11.8% with bronchopulmonary dysplasia (BPD) at 28 days of life. Mean FiO₂ was 0.4 at baseline, and 0.32 at 4 h posttreatment.

Conclusions: Aerosurf can be safely administered via nCPAP in preterm infants at risk for RDS and may provide an alternative to surfactant administration via an ET tube. Further studies are required to evaluate this delivery approach.

Publication types

  • Clinical Trial, Phase II
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aerosols
  • Bronchopulmonary Dysplasia / epidemiology
  • Combined Modality Therapy
  • Continuous Positive Airway Pressure / methods*
  • Drug Combinations
  • Fatty Alcohols / administration & dosage*
  • Fatty Alcohols / adverse effects
  • Fatty Alcohols / therapeutic use
  • Humans
  • Infant, Newborn
  • Infant, Premature
  • Oxygen / metabolism
  • Phosphatidylglycerols / administration & dosage*
  • Phosphatidylglycerols / adverse effects
  • Phosphatidylglycerols / therapeutic use
  • Pilot Projects
  • Proteins / administration & dosage*
  • Proteins / adverse effects
  • Proteins / therapeutic use
  • Respiratory Distress Syndrome, Newborn / prevention & control*
  • Time Factors


  • Aerosols
  • Drug Combinations
  • Fatty Alcohols
  • Phosphatidylglycerols
  • Proteins
  • lucinactant
  • Oxygen