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Genetic Susceptibility for Bronchopulmonary Dysplasia in Preterm Infants (GENBPD)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2009 by Centre Hospitalier Intercommunal Creteil.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT00904774
First Posted: May 20, 2009
Last Update Posted: May 20, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Centre Hospitalier Intercommunal Creteil
  Purpose

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).

Condition
Bronchopulmonary Dysplasia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Polymorphisms of Genes Controlling Alveolar Development and Risk of Bronchopulmonary Dysplasia

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Intercommunal Creteil:

Primary Outcome Measures:
  • bronchopulmonary dysplasia [ Time Frame: 36 weeks of postconceptional age ]

Estimated Enrollment: 800
Study Start Date: May 2009
Groups/Cohorts
premature neonates
gestational age less than 28 weeks

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 8 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Premature neonates
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00904774


Locations
France
Centre Hospitalier Intercommunal
Creteil, France, 94000
Sponsors and Collaborators
Centre Hospitalier Intercommunal Creteil
  More Information

Additional Information:
Publications:
Responsible Party: Delacourt, Christophe, MD, PhD, INSERM U955
ClinicalTrials.gov Identifier: NCT00904774     History of Changes
Other Study ID Numbers: AOR 07 018
First Submitted: May 19, 2009
First Posted: May 20, 2009
Last Update Posted: May 20, 2009
Last Verified: May 2009

Keywords provided by Centre Hospitalier Intercommunal Creteil:
bronchopulmonary dysplasia
neonates
lung development
prematurity

Additional relevant MeSH terms:
Hyperplasia
Bronchopulmonary Dysplasia
Pathologic Processes
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases