- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00904774
Genetic Susceptibility for Bronchopulmonary Dysplasia in Preterm Infants (GENBPD)
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:
- a genome-wide association (GWA) study in VLBW neonates,
- a candidate-gene association study, including selection of single nucleotide polymorphisms (SNPs) found in (a) and
- functional studies of any SNP found to be convincingly associated with BPD in (a) and (b).
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
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-
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Creteil, Frankrig, 94000
- Centre Hospitalier Intercommunal
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
premature neonates
gestational age less than 28 weeks
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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bronchopulmonary dysplasia
Tidsramme: 36 weeks of postconceptional age
|
36 weeks of postconceptional age
|
Samarbejdspartnere og efterforskere
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- AOR 07 018
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