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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier:
NCT01102543
First received: April 12, 2010
Last updated: April 5, 2012
Last verified: April 2012
History of Changes
  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:

MedlinePlus related topics: Premature Babies
U.S. FDA Resources

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

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

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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Newborn
prophylaxis

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

ClinicalTrials.gov processed this record on June 17, 2013