Ignite Creation Date:
2024-05-05 @ 11:51 PM
Last Modification Date:
2024-10-26 @ 10:41 AM
Study NCT ID:
NCT01439048
Status:
COMPLETED
Last Update Posted:
2015-08-28
First Post:
2011-09-21
Brief Title:
Placental and Cord Blood Markers Associated With Premature Birth and Disorders of Premature Birth in Newborn Infants
Sponsor:
Medical College of Wisconsin
Organization:
Medical College of Wisconsin
Study Overview
Official Title:
Study of Environmental Toxicants and Inflammatory Markers in Prematurity and Diseases of Prematurity
Status:
COMPLETED
Status Verified Date:
2015-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine if changes in specific gene products in the placenta or cordinfant blood affect a babys birth weight increase the risk of premature birth or increase the risk of developing diseases of prematurity We would also like to characterize whether placental epigenetic changes or placental markers of environmental exposures are associated with premature birth
Detailed Description:
Prematurity diseases of prematurity and growth-disorders of newborn infants contribute significantly to morbidity and mortality seen in newborn infants 123 One out of eight newborn infants in the USA is born premature gestational age less than 37 completed weeks In 2004 of the 27860 infants dying within the first year of life greater than 16000 were born premature 2 Moreover premature infants who survive the neonatal period are at increased risk of cerebral palsy developmental delays growth impairment and long-term respiratory disability 3-5 Additionally fetal growth restriction and fetal growth excess results in infants being delivered as small for gestational age infants or large for gestational age infants respectively Infants born with such growth-disorders are at increased risk of perinatal morbidity and mortality and as adults are at significant risk of obesity type II diabetes and heart disease 67
While the etiology of preterm birth and growth-disorders can be ascribed to maternal conditions chromosomal defects or specific maternal environmental exposures in some newborn infants for a majority the etiology remains unknown 89 There is increasing evidence pointing to the role of genetic susceptibility factors in the causation of prematurity and growth-disorders of the newborn infant 8 10-12 Further epigenetic changes in growth regulating or inflammatory genes in the placenta can program the fetus for premature birth growth-disorders and other diseases in the postnatal period
The overall objective of this application is four-fold
1 To determine whether altered placental or fetal expression of imprinted genes is associated with disorders of growth prematurity or other postnatal diseases in newborn infants
2 To determine whether altered placental expression of genes that regulate the innate immune response is associated with premature birth or other postnatal diseases in newborn infants
3 To determine whether placental markers of environmental exposure such as Polycyclic Aromatic Hydrocarbons or PAH or epigenetic changes in placental inflammatory genes or growth genes are associated with prematurity or postnatal diseases in newborn infants
4 To determine whether cord blood immune responses and markers of immune-cell function are different between preterm and term infants and are associated with postnatal diseases in preterm infants
While the etiology of preterm birth and growth-disorders can be ascribed to maternal conditions chromosomal defects or specific maternal environmental exposures in some newborn infants for a majority the etiology remains unknown 89 There is increasing evidence pointing to the role of genetic susceptibility factors in the causation of prematurity and growth-disorders of the newborn infant 8 10-12 Further epigenetic changes in growth regulating or inflammatory genes in the placenta can program the fetus for premature birth growth-disorders and other diseases in the postnatal period
The overall objective of this application is four-fold
1 To determine whether altered placental or fetal expression of imprinted genes is associated with disorders of growth prematurity or other postnatal diseases in newborn infants
2 To determine whether altered placental expression of genes that regulate the innate immune response is associated with premature birth or other postnatal diseases in newborn infants
3 To determine whether placental markers of environmental exposure such as Polycyclic Aromatic Hydrocarbons or PAH or epigenetic changes in placental inflammatory genes or growth genes are associated with prematurity or postnatal diseases in newborn infants
4 To determine whether cord blood immune responses and markers of immune-cell function are different between preterm and term infants and are associated with postnatal diseases in preterm infants
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None