A Double Blind, Randomized, Controlled Study to Compare CHF 5633 (Synthetic Surfactant) and Poractant Alfa in RDS

Inclusion Criteria:

1. Written informed consent obtained by parents/legal representative (according to local
regulation) prior to any study-related procedures

2. Inborn preterm neonates of either sex with a gestational age of 24+0 weeks up to 29+6
weeks

3. Clinical course consistent with RDS

4. Requirement of endotracheal surfactant administration within 24 hours from birth

5. Fraction of inspired oxygen (FiO2) ≥0.30 for babies 24+0 to 26+6 weeks and FiO2 ≥0.35
for babies 27+0 to 29+6 weeks to maintain SpO2 between 88-95%

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.