Bronchopulmonary DysplasiaGENBPDNCT00904774
Genetic Susceptibility for Bronchopulmonary Dysplasia in Preterm Infants
An observational study of Bronchopulmonary Dysplasia, run by Centre Hospitalier Intercommunal Creteil at 1 site in France.
Trial summary
Despite considerable obstetric and neonatal advances in the care of very low birth weight (VLBW) neonates, bronchopulmonary dysplasia (BPD) continues to occur among 20 to 40% of surviving infants, and new ways for combatting this disease must be found. Read more about this study
- Who is it for?
- Ages Up to 8 weeks
- Conditions the study is for
- Bronchopulmonary Dysplasia
- How many people
- 800 participants
- Where
- 1 siteFrance
- Study dates
- May 2009to not given
- 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 Up to 8 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Premature neonates
Who may be able to join
- Gestational age < 28 weeks
- Inborn birth
- Prophylactic administration of surfactant in the delivery room
- Written informed consent obtained from parents
Who cannot join
- Gestational age of 28 weeks or more
- Outborn birth
- No prophylactic administration of surfactant in the delivery room
- Congenital malformation
- Absence of written informed consent obtained from parents
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Polymorphisms of Genes Controlling Alveolar Development and Risk of Bronchopulmonary Dysplasia
Despite considerable obstetric and neonatal advances in the care of very low birth weight (VLBW) neonates, bronchopulmonary dysplasia (BPD) continues to occur among 20 to 40% of surviving infants, and new ways for combatting this disease must be found. BPD appears to result from arrested lung development, but its etiology has not yet been fully established. Besides the role of the exposure of the immature lung to injurious factors in the development of BPD, a genetic susceptibility for BPD in preterm infants was recently evidenced. Taking advantage of new genomic technologies, the objective of the investigators' project is to identify predisposing human genetic variants through:
- a genome-wide association (GWA) study in VLBW neonates,
- a candidate-gene association study, including selection of single nucleotide polymorphisms (SNPs) found in (a) and
- functional studies of any SNP found to be convincingly associated with BPD in (a) and (b).
- Conditions
- Bronchopulmonary Dysplasia
- Keywords
- bronchopulmonary dysplasia, neonates, lung development, prematurity
- Medical subject headings
- Bronchopulmonary Dysplasia, Premature Birth
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 neonates | gestational age less than 28 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
bronchopulmonary dysplasia
Measured: 36 weeks of postconceptional age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2009 (estimated)
- Study startMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bronchopulmonary DysplasiaStudies of the same condition, open and under way.
- 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
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00904774
- Sponsor's protocol ID
- AOR 07 018
- Acronym
- GENBPD
- Status last verified
- May 2009
- First submitted
- 19 May 2009
- Last updated
- 20 May 2009
- Results posted
- No
Publications
Hadchouel A, Decobert F, Franco-Montoya ML, Halphen I, Jarreau PH, Boucherat O, Martin E, Benachi A, Amselem S, Bourbon J, Danan C, Delacourt C. Matrix metalloproteinase gene polymorphisms and bronchopulmonary dysplasia: identification of MMP16 as a new player in lung development. PLoS One. 2008 Sep 11;3(9):e3188. doi: 10.1371/journal.pone.0003188.
PubMed 18784838
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polymorphisms of Genes Controlling Alveolar Development and Risk of Bronchopulmonary Dysplasia
- ClinicalTrials.gov ID
- NCT00904774
- Acronym / sponsor ID
- GENBPD / AOR 07 018
- Conditions
- Bronchopulmonary Dysplasia
- Keywords
- bronchopulmonary dysplasia, neonates, lung development, prematurity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Study start
- May 2009
- First posted
- 20 May 2009 (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.
Despite considerable obstetric and neonatal advances in the care of very low birth weight (VLBW) neonates, bronchopulmonary dysplasia (BPD) continues to occur among 20 to 40% of surviving infants, and new ways for combatting this disease must be found. BPD appears to result from arrested lung development, but its etiology has not yet been fully established. Besides the role of the exposure of the immature lung to injurious factors in the development of BPD, a genetic susceptibility for BPD in preterm infants was recently evidenced. Taking advantage of new genomic technologies, the objective of the investigators' project is to identify predisposing human genetic variants through:
- a genome-wide association (GWA) study in VLBW neonates,
- a candidate-gene association study, including selection of single nucleotide polymorphisms (SNPs) found in (a) and
- functional studies of any SNP found to be convincingly associated with BPD in (a) and (b).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| premature neonates | – | –gestational age less than 28 weeks |
Who may qualify
- Ages
- Up to 8 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Premature neonates
Key inclusion criteria (4 listed)
- Gestational age < 28 weeks
- Inborn birth
- Prophylactic administration of surfactant in the delivery room
- Written informed consent obtained from parents
Key exclusion criteria (5 listed)
- Gestational age of 28 weeks or more
- Outborn birth
- No prophylactic administration of surfactant in the delivery room
- Congenital malformation
- Absence of written informed consent obtained from 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
bronchopulmonary dysplasia
Time frame: 36 weeks of postconceptional age
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2009.
- Background: PubMed 18784838Hadchouel A, Decobert F, Franco-Montoya ML, Halphen I, Jarreau PH, Boucherat O, Martin E, Benachi A, Amselem S, Bourbon J, Danan C, Delacourt C. Matrix metalloproteinase gene polymorphisms and bronchopulmonary dysplasia: identification of MMP16 as a new player in lung development. PLoS One. 2008 Sep 11;3(9):e3188. doi: 10.1371/journal.pone.0003188.
- The french PremUp Foundation is dedicated to pregnancy and the newbornLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Bronchopulmonary Dysplasia, run by Centre Hospitalier Intercommunal Creteil 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 20 May 2009. 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?
Results are not available in the source record.
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.
What does the primary outcome measure?
bronchopulmonary dysplasia (time frame: 36 weeks of postconceptional age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00904774, which also lists 1 linked publication.
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 20 May 2009.