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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01102543
First Posted: April 13, 2010
Last Update Posted: April 6, 2012
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.
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.
  Purpose
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
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)
Groups/Cohorts
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.
  Eligibility

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
Criteria

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
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 ClinicalTrials.gov identifier (NCT number): NCT01102543


Locations
France
Laboratoire Chiesi S.A.
Courbevoie, France, 92407
Sponsors and Collaborators
Chiesi Farmaceutici S.p.A.
Investigators
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
First Submitted: April 12, 2010
First Posted: April 13, 2010
Last Update Posted: April 6, 2012
Last Verified: April 2012

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

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