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CompletedNCT01102543Updated Apr 6, 2012

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

An observational study in Respiratory Distress Syndrome, Newborn, sponsored by Chiesi Farmaceutici S.p.A.. Completed at 1 site in France. Open to participants aged 1 Minute to 12 Hours. Per ClinicalTrials.gov, last updated 2012-04-06.

Sponsored by Chiesi Farmaceutici S.p.A. · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
972
Ages
1 Minute to 12 Hours
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Respiratory Distress Syndrome, Newborn

Keywords

  • pulmonary surfactant
  • Respiratory distress syndrome
  • Newborn
  • prophylaxis
03

In context

Respiratory Distress Syndrome

1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.

This study's enrollment of 972 is above the median of 100 across 540 observational studies indexed under Respiratory Distress Syndrome.

Browse Respiratory Distress Syndrome studies →

Lead sponsor

Chiesi Farmaceutici S.p.A. is the lead sponsor of 182 studies on the registry; 22 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 11 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Minute to 12 Hours
Sexes eligible
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

Inclusion criteria

  • during the study, each neonatologist will have to include all the babies born with a gestational age \< 32 GA

Exclusion criteria

Exclusion Criteria:

  • gestational age > 32 GA
  • No consent to the data collection by one of the parents
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
972 participants (actual)

Groups and cohorts

  • Premature babies < 28 GA
  • Premature babies > 28 & < 32 weeks GA
06

Study locations

1 site
  • Laboratoire Chiesi S.A.
    Courbevoie, 92407, France
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 6, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT01102543
Lead sponsor
Chiesi Farmaceutici S.p.A.
Responsible party
Sponsor
First posted
Apr 13, 2010
Start date
Mar 2010
Primary completion
Oct 2010
Completion
Mar 2011
Last update
Apr 6, 2012

Study contacts

Capucine de Meynard, MD
study director · Chiesi S.A.

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.

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