Observational Study on the Prophylactic Use of Curosurf in Neonatal Respiratory Distress Syndrome (RDS)

This study has been completed.
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier:
First received: April 12, 2010
Last updated: April 5, 2012
Last verified: April 2012
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 Type: Observational
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.

Resource links provided by NLM:

Further study details as provided by Chiesi Farmaceutici S.p.A.:

Enrollment: 972
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

Detailed Description:
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.

Ages Eligible for Study:   up to 12 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
900 premature babies in 2 groups/cohorts : group 1 - babies born before 28 weeks GA ; groupe 2 - babies born at 28 - 32 weeks GA

Inclusion Criteria:

  • during the study, each neonatologist will have to include all the babies born with a gestational age < 32 GA

Exclusion Criteria:

  • gestational age > 32 GA
  • No consent to the data collection by one of the parents
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01102543

Laboratoire Chiesi S.A.
Courbevoie, France, 92407
Sponsors and Collaborators
Chiesi Farmaceutici S.p.A.
Study Director: Capucine de Meynard, MD Chiesi S.A.
  More Information

Responsible Party: Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier: NCT01102543     History of Changes
Other Study ID Numbers: CUR7101 
Study First Received: April 12, 2010
Last Updated: April 5, 2012
Health Authority: France: Haute Autorité de Santé Transparency Commission

Keywords provided by Chiesi Farmaceutici S.p.A.:
pulmonary surfactant
Respiratory distress syndrome

Additional relevant MeSH terms:
Hyaline Membrane Disease
Respiratory Distress Syndrome, Adult
Respiratory Distress Syndrome, Newborn
Infant, Newborn, Diseases
Infant, Premature, Diseases
Lung Diseases
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 26, 2016