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Genetic Susceptibility for Bronchopulmonary Dysplasia in Preterm Infants (GENBPD)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Centre Hospitalier Intercommunal Creteil
ClinicalTrials.gov Identifier:
NCT00904774
First received: May 19, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted
  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:

MedlinePlus related topics: Premature Babies
U.S. FDA Resources

Further study details as provided by Centre Hospitalier Intercommunal Creteil:

Primary Outcome Measures:
  • bronchopulmonary dysplasia [ Time Frame: 36 weeks of postconceptional age ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   up to 8 Weeks
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00904774

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

Additional Information:
The french PremUp Foundation is dedicated to pregnancy and the newborn  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Delacourt, Christophe, MD, PhD, INSERM U955
ClinicalTrials.gov Identifier: NCT00904774     History of Changes
Other Study ID Numbers: AOR 07 018
Study First Received: May 19, 2009
Last Updated: May 19, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Bronchopulmonary Dysplasia
Disease Susceptibility
Genetic Predisposition to Disease
Hyperplasia
Ventilator-Induced Lung Injury
Lung Injury
 Lung Diseases
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013