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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01102543
Recruitment Status : Completed
First Posted : April 13, 2010
Last Update Posted : April 6, 2012
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.

Brief Summary:
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.

Condition or disease
Respiratory Distress Syndrome, Newborn

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.

Study Type : Observational
Actual Enrollment : 972 participants
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
Actual Primary Completion Date : October 2010
Actual Study Completion Date : March 2011

Premature babies < 28 GA
Premature babies > 28 & < 32 weeks GA

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 12 Hours   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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.

Responsible Party: Chiesi Farmaceutici S.p.A. Identifier: NCT01102543     History of Changes
Other Study ID Numbers: CUR7101
First Posted: April 13, 2010    Key Record Dates
Last Update Posted: April 6, 2012
Last Verified: April 2012

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

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Hyaline Membrane Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Poractant alfa
Pulmonary Surfactants
Respiratory System Agents