A Double Blind, Randomized, Controlled Study to Evaluate CHF 5633 (Synthetic Surfactant) and Poractant Alfa in Neonates With Respiratory Distress Syndrome (RDS) (POC)

Exclusion Criteria

• •1. Use of surfactant prior to study entry and need for intratracheal administration of any other treatment (e.g. nitric oxide)
• •2. Known genetic or chromosomal disorders, major congenital anomalies (cardiac malformations, myelomeningocele etc)
• •3. Maternal drug abuse (heroin, methadone, methamphetamine, or cocaine) or significant alcohol consumption during pregnancy
• •4. Mothers with prolonged rupture of the membranes (\>21 days duration)
• •5. Strong suspicion of congenital pneumonia/infection, sepsis
• •6. Presence of air leaks prior to study entry
• •7. Evidence of severe birth asphyxia
• •8. Neonatal seizures prior to study entry
• •9. Any condition that, in the opinion of the Investigator, would place the neonate at undue risk
• •10. Participation in another clinical trial of any placebo, drug or biological substance conducted under the provisions of a protocol.