Study On Safety And Efficacy Of A New Drug CHF 5633 To Treat Respiratory Failure In Premature Babies

Update Il y a 4 ans
Reference: EUCTR2011-001331-22

Woman and Man

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Extract

The primary aim of this study is to evaluate 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 (AEs) and adverse drug reactions (ADRs), haematology and biochemistry values and incidence of major neonatal morbidities and mortality.


Inclusion criteria

  • preterm neonates with Respiratory Distress Syndrome (RDS)