Observational Study on the Prophylactic Use of Curosurf in Neonatal Respiratory Distress Syndrome (RDS)
The aim of Alizé is to describe a population of premature babies (gestational age (GA) < 32 weeks) in real life situation and the management of RDS.
Respiratory Distress Syndrome, Newborn
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Observational Study in Neonatal Intensive Care Units (NICU) on the Real Life Use of Curosurf in Prophylaxis of RDS in Premature Babies.|
|Study Start Date:||March 2010|
|Study Completion Date:||March 2011|
|Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
|Premature babies < 28 GA|
|Premature babies > 28 & < 32 weeks GA|
Description includes gestational age, birth clinical characteristics in particular the respiratory function, evaluation of the mother prenatal corticosteroids treatment in prophylaxis of RDS, mother medical and obstetric history, premature babies care in the delivery room with a special focus on the Curosurf use: prophylactic or curative use / other surfactant / no surfactant. A special focus is on the Prophylactic use.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01102543
|Laboratoire Chiesi S.A.|
|Courbevoie, France, 92407|
|Study Director:||Capucine de Meynard, MD||Chiesi S.A.|