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NCT01102543 Clinical Trial

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

Respiratory Distress Syndrome, Newborn Clinical Trial

Official title:
Observational Study in Neonatal Intensive Care Units (NICU) on the Real Life Use of Curosurf in Prophylaxis of RDS in Premature Babies.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01102543
Other study ID # CUR7101
Secondary ID
Status Completed
Phase N/A
First received April 12, 2010
Last updated April 5, 2012
Start date March 2010
Est. completion date March 2011

Study information
Verified date April 2012
Source Chiesi Farmaceutici S.p.A.
Contact n/a
Is FDA regulated No
Health authority France: Haute Autorité de Santé Transparency Commission
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 972
Est. completion date March 2011
Est. primary completion date October 2010
Accepts healthy volunteers No
Gender Both
Age group N/A to 12 Hours
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
France Laboratoire Chiesi S.A. Courbevoie

Sponsors (1)
Lead Sponsor Collaborator
Chiesi Farmaceutici S.p.A.

Country where clinical trial is conducted

France, 

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