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

Mise à jour : Il y a 4 ans
Référence : EUCTR2011-001331-22

Femme et Homme

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Extrait

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.


Critère d'inclusion

  • preterm neonates with Respiratory Distress Syndrome (RDS)