Respiratory Distress Syndrome, NewbornNCT01102543
Observational Study on the Prophylactic Use of Curosurf in Neonatal Respiratory Distress Syndrome (RDS)
An observational study of Respiratory Distress Syndrome, Newborn, run by Chiesi Farmaceutici S.p.A. at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 1 minute to 12 hours
- Conditions the study is for
- Respiratory Distress Syndrome, Newborn
- How many people
- 972 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2010to Mar 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 minute to 12 hours
- All sexes
- No healthy volunteers
- Child
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
Who may be able to join
- during the study, each neonatologist will have to include all the babies born with a gestational age < 32 GA
Who cannot join
- gestational age > 32 GA
- No consent to the data collection by one of the parents
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Study in Neonatal Intensive Care Units (NICU) on the Real Life Use of Curosurf in Prophylaxis of RDS in Premature Babies.
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.
- Conditions
- Respiratory Distress Syndrome, Newborn
- Keywords
- pulmonary surfactant, Respiratory distress syndrome, Newborn, prophylaxis
- Medical subject headings
- Respiratory Distress Syndrome, Newborn, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Premature babies < 28 GA | Not described | |
| Premature babies > 28 & < 32 weeks GA | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2010 (estimated)
- Study startMar 2010
- Primary completionOct 2010
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress Syndrome, NewbornStudies of the same condition, open and under way.
- More trials run by Chiesi Farmaceutici S.p.A.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 972 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Capucine de Meynard, MD, Study director, Chiesi S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01102543
- Sponsor's protocol ID
- CUR7101
- Status last verified
- Apr 2012
- First submitted
- 12 Apr 2010
- Last updated
- 6 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study in Neonatal Intensive Care Units (NICU) on the Real Life Use of Curosurf in Prophylaxis of RDS in Premature Babies.
- ClinicalTrials.gov ID
- NCT01102543
- Acronym / sponsor ID
- CUR7101
- Conditions
- Respiratory Distress Syndrome, Newborn
- Keywords
- pulmonary surfactant, Respiratory distress syndrome, Newborn, prophylaxis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 972 participants (actual)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 13 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Premature babies < 28 GA | – | – |
| Premature babies > 28 & < 32 weeks GA | – | – |
Who may qualify
- Ages
- 1 minute to 12 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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
Key inclusion criteria (1 listed)
- during the study, each neonatologist will have to include all the babies born with a gestational age < 32 GA
Key exclusion criteria (2 listed)
- gestational age > 32 GA
- No consent to the data collection by one of the parents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Capucine de Meynard, MD study director
Chiesi S.A.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Distress Syndrome, Newborn, run by Chiesi Farmaceutici S.p.A. at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2012; AzTrials last refreshed its copy on 7 Nov 2026.