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NCT00904774 Clinical Trial

Genetic Susceptibility for Bronchopulmonary Dysplasia in Preterm Infants

Bronchopulmonary Dysplasia Clinical Trial

— GENBPD  

Official title:
Polymorphisms of Genes Controlling Alveolar Development and Risk of Bronchopulmonary Dysplasia

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT00904774
Other study ID # AOR 07 018
Secondary ID
Status Enrolling by invitation
Phase N/A
First received May 19, 2009
Last updated May 19, 2009
Start date May 2009

Study information
Verified date May 2009
Source Centre Hospitalier Intercommunal Creteil
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Observational

Clinical 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. 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:

1. a genome-wide association (GWA) study in VLBW neonates,

2. a candidate-gene association study, including selection of single nucleotide polymorphisms (SNPs) found in (a) and

3. functional studies of any SNP found to be convincingly associated with BPD in (a) and (b).

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 800
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A to 8 Weeks
Eligibility Inclusion Criteria:

- Gestational age < 28 weeks

- Inborn birth

- Prophylactic administration of surfactant in the delivery room

- Written informed consent obtained from parents

Exclusion Criteria:

- 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
France Centre Hospitalier Intercommunal Creteil

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Intercommunal Creteil

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary bronchopulmonary dysplasia 36 weeks of postconceptional age No
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