NCT01102543

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
972

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 12, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 13, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

April 6, 2012

Status Verified

April 1, 2012

Enrollment Period

7 months

First QC Date

April 12, 2010

Last Update Submit

April 5, 2012

Conditions

Respiratory Distress Syndrome, Newborn

Keywords

pulmonary surfactantRespiratory distress syndromeNewbornprophylaxis

Study Arms (2)

Premature babies < 28 GA

Premature babies > 28 & < 32 weeks GA

Eligibility Criteria

Age1 Minute - 12 Hours
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability 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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratoire Chiesi S.A.

Courbevoie, 92407, France

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome, NewbornRespiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration DisordersInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Capucine de Meynard, MD

    Chiesi S.A.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2010

First Posted

April 13, 2010

Study Start

March 1, 2010

Primary Completion

October 1, 2010

Study Completion

March 1, 2011

Last Updated

April 6, 2012

Record last verified: 2012-04

Locations

FR(1)