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An open label, randomized, controlled study to evaluate the safety and efficacy of aerosolized surfactant, Curosurf®, delivered via nasal continuous positive airway pressure pulmonary drug delivery sy...

Update Il y a 4 ans
Reference: EUCTR2005-000489-37

An open label, randomized, controlled study to evaluate the safety and efficacy of aerosolized surfactant, Curosurf®, delivered via nasal continuous positive airway pressure pulmonary drug delivery system (NCPAP PDDS) in infants with respiratory distress syndrome

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Extract

The primary objective is to evaluate the safety of aerosolized Curosurf delivered via nasal continuous positive airway pressure (NCPAP) in infants with RDS.

Inclusion criteria

  • The medical condition for this application is the Respiratory Distress Syndrome (RDS). RDS, also known as hyaline membrane disease, is characterized by lung immaturity and surfactant deficiency and is the most common respiratory disorder in premature infants. The first clinical manifestations of RDS at birth are grunting respiration, subcostal and intercostal retractions, cyanosis and nasal flaring

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