NCT00904774

Brief 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. 1.a genome-wide association (GWA) study in VLBW neonates,
  2. 2.a candidate-gene association study, including selection of single nucleotide polymorphisms (SNPs) found in (a) and
  3. 3.functional studies of any SNP found to be convincingly associated with BPD in (a) and (b).

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

May 19, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 20, 2009

Completed
Last Updated

May 20, 2009

Status Verified

May 1, 2009

First QC Date

May 19, 2009

Last Update Submit

May 19, 2009

Conditions

Keywords

bronchopulmonary dysplasianeonateslung developmentprematurity

Outcome Measures

Primary Outcomes (1)

  • bronchopulmonary dysplasia

    36 weeks of postconceptional age

Study Arms (1)

premature neonates

gestational age less than 28 weeks

Eligibility Criteria

AgeUp to 8 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Premature neonates

You may qualify if:

  • Gestational age \< 28 weeks
  • Inborn birth
  • Prophylactic administration of surfactant in the delivery room
  • Written informed consent obtained from parents

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Intercommunal

Créteil, 94000, France

Location

Related 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.

    PMID: 18784838BACKGROUND

Related Links

MeSH Terms

Conditions

Bronchopulmonary DysplasiaPremature Birth

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung InjuryLung InjuryLung DiseasesRespiratory Tract DiseasesInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 19, 2009

First Posted

May 20, 2009

Study Start

May 1, 2009

Last Updated

May 20, 2009

Record last verified: 2009-05

Locations