First In Human Study on Synthetic Surfactant CHF 5633 in Respiratory Distress Syndrome

The study will be a multicentre, open-label, single escalating dose, per-cohort design.

Inclusion criteria

• Written informed consent obtained by parents/legal representative (according to local regulation) prior to any study-related procedures
• Inborn and outborn, preterm neonates of either sex with a gestational age of 27 weeks up to 33 weeks+6
• Clinical and radiological findings typical of RDS
• Age on admission to the study < 24 hours from birth
• Requirement of endotracheal intubation for surfactant administration
• Fraction of inspired oxygen (FiO2) > 0.35 to maintain SpO2 between 90-95 %
• Documentation of normal cranial ultrasound scan

Exclusion criteria

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