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Clinical Trials/NCT01102543
NCT01102543CompletedNot Applicable

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

Chiesi Farmaceutici S.p.A.1 site in 1 country972 target enrollmentStarted: March 2010Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
972
Locations
1
Study OverviewStudy DesignEligibility CriteriaInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
1 Minute to 12 Hours (Child)
Sex
All
Accepts Healthy Volunteers
No

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

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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