An open label, pilot study of Aerosurf® combined with nCPAP to prevent RDS in preterm neonates.
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.
Finer
Neil N
NN
Department of Pediatrics, University of California San Diego, San Diego, California 92103, USA. nfiner@ucsd.edu
Merritt
T Allen
TA
Bernstein
Graham
G
Job
Leela
L
Mazela
Jan
J
Segal
Robert
R
D000336:Aerosols; D001997:Bronchopulmonary Dysplasia / Q000453:epidemiology; D003131:Combined Modality Therapy; D045422:Continuous Positive Airway Pressure / Q000379:methods*; D004338:Drug Combinations; D005233:Fatty Alcohols / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D007231:Infant, Newborn; D007234:Infant, Premature; D010100:Oxygen / Q000378:metabolism; D010715:Phosphatidylglycerols / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D010865:Pilot Projects; D011506:Proteins / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D012127:Respiratory Distress Syndrome, Newborn / Q000517:prevention & control*; D013997:Time Factors
D000336:Aerosols; D004338:Drug Combinations; D005233:Fatty Alcohols; D010715:Phosphatidylglycerols; D011506:Proteins; C502722:lucinactant; D010100:Oxygen