The present study will mainly aim at investigating the safety, tolerability and efficacy of different escalating single doses administration of nebulised Curosurf®, in preterm neonates with RDS (Respiratory Distress Syndrome) during nCPAP.
The study will be conducted in spontaneously breathing preterm neonates with mild to moderate RDS and will consist of two parts: Part I, with the objective to assess the safety and tolerability of single ascending doses of nebulised Curosurf® ; Part II, with the objective to compare the efficacy of nebulised Curosurf®, administered at two selected doses from part I, during nCPAP, versus nCPAP alone in terms of incidence of respiratory failure in the first 72 hours of life.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
166
Single ascending doses of Curosurf® administered through nebulisation to neonates receiving nCPAP (Part I)
Two doses of Curosurf® administered through nebulisation to neonates receiving nCPAP (Part II)
Nasal continuous positive airway pressure alone
Prof.Carlo Dani, Coordinating Investigator - Careggi Hospital, Florence (Italy)
Florence, Italy
Percentage of neonates with respiratory failure
Respiratory failure defined as: need for endotracheal surfactant administration and/or mechanical ventilation
Time frame: in the first 72 hours of life
Adverse Events
Any untoward medical occurrence in a clinical trial neonate administered a medicinal product and which does not necessarily have a casual relationship with the treatment
Time frame: discharge or 36 weeks post menstrual age (PMA), whichever comes first
Adverse Drug Reactions
Any untoward and unintended responses to an investigational product related to any dose administered
Time frame: discharge or 36 weeks post menstrual age (PMA), whichever comes first
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nasal continuous positive airway pressure alone