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

NCT ID: NCT01102543

Last Updated: 2012-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

972 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-03-31

Brief Summary

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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

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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.

Conditions

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Respiratory Distress Syndrome, Newborn

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Premature babies < 28 GA

No interventions assigned to this group

Premature babies > 28 & < 32 weeks GA

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

1 Minute

Maximum Eligible Age

12 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chiesi Farmaceutici S.p.A.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Capucine de Meynard, MD

Role: STUDY_DIRECTOR

Chiesi S.A.

Locations

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Laboratoire Chiesi S.A.

Courbevoie, , France

Site Status

Countries

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France

Other Identifiers

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CUR7101

Identifier Type: -

Identifier Source: org_study_id

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