Genetic Susceptibility for Bronchopulmonary Dysplasia in Preterm Infants (GENBPD)

May 19, 2009 updated by: Centre Hospitalier Intercommunal Creteil

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:

  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).

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Creteil, France, 94000
        • Centre Hospitalier Intercommunal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 month (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Premature neonates

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
premature neonates
gestational age less than 28 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
bronchopulmonary dysplasia
Time Frame: 36 weeks of postconceptional age
36 weeks of postconceptional age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Intercommunal Creteil

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Study Registration Dates

First Submitted

May 19, 2009

First Submitted That Met QC Criteria

May 19, 2009

First Posted (Estimate)

May 20, 2009

Study Record Updates

Last Update Posted (Estimate)

May 20, 2009

Last Update Submitted That Met QC Criteria

May 19, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AOR 07 018

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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