2 part study in spontaneously breathing preterm neonates with mild to moderate respiratory distress syndrome

Mise à jour : Il y a 4 ans
Référence : EUCTR2016-004547-36

Femme et Homme

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Extrait

Part I: Objective To assess the safety and tolerability of three single ascending doses of nebulized Curosurf®. Part II Objective To compare the efficacy of nebulized Curosurf®, administered at low dose (dose 1) or high dose (dose 2), during nCPAP, versus nCPAP alone in terms of incidence of respiratory failure in the first 72 hours of life in spontaneously breathing preterm neonates with mild to moderate RDS.


Critère d'inclusion

  • Mild to moderate respiratory distress syndrome

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