First In Human Study on Synthetic Surfactant CHF 5633 in Respiratory Distress Syndrome
Status:
Completed
Trial end date:
2015-01-23
Target enrollment:
Participant gender:
Summary
The aim of this study is to investigate the safety and tolerability of intratracheal
administration of two different single doses of CHF 5633 in preterm neonates with RDS in
terms of adverse events, adverse drug reactions, hematology and biochemistry values, the
incidence of major neonatal morbidities including bronchopulmonary dysplasia (BPD) and
mortality.