Placental and Cord Blood Markers Associated With Premature Birth and Disorders of Premature Birth in Newborn Infants
NCT ID: NCT01439048
Last Updated: 2015-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
82 participants
OBSERVATIONAL
2009-06-30
2015-08-31
Brief Summary
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Detailed Description
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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 \[8,9\]. 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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Term infants
Infants born at greater than 37 weeks gestation
No interventions assigned to this group
Preterm Infants
Infants born at less than 37 weeks gestation
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
1 Minute
3 Months
ALL
Yes
Sponsors
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Medical College of Wisconsin
OTHER
Responsible Party
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Venkatesh Sampath
Staff Physician
Principal Investigators
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Venkatesh Sampath, MBBS
Role: PRINCIPAL_INVESTIGATOR
Medical College of Wisconsin
Locations
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Froedtert Memorial Lutheran Hospital
Wauwatosa, Wisconsin, United States
Countries
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References
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Guyer B, Martin JA, MacDorman MF, Anderson RN, Strobino DM. Annual summary of vital statistics--1996. Pediatrics. 1997 Dec;100(6):905-18. doi: 10.1542/peds.100.6.905.
Mathews TJ, MacDorman MF. Infant mortality statistics from the 2003 period linked birth/infant death data set. Natl Vital Stat Rep. 2006 May 3;54(16):1-29.
Stoll BJ, Hansen N. Infections in VLBW infants: studies from the NICHD Neonatal Research Network. Semin Perinatol. 2003 Aug;27(4):293-301. doi: 10.1016/s0146-0005(03)00046-6.
Stoll BJ, Hansen N, Fanaroff AA, Wright LL, Carlo WA, Ehrenkranz RA, Lemons JA, Donovan EF, Stark AR, Tyson JE, Oh W, Bauer CR, Korones SB, Shankaran S, Laptook AR, Stevenson DK, Papile LA, Poole WK. Late-onset sepsis in very low birth weight neonates: the experience of the NICHD Neonatal Research Network. Pediatrics. 2002 Aug;110(2 Pt 1):285-91. doi: 10.1542/peds.110.2.285.
Stoll BJ, Hansen NI, Adams-Chapman I, Fanaroff AA, Hintz SR, Vohr B, Higgins RD; National Institute of Child Health and Human Development Neonatal Research Network. Neurodevelopmental and growth impairment among extremely low-birth-weight infants with neonatal infection. JAMA. 2004 Nov 17;292(19):2357-65. doi: 10.1001/jama.292.19.2357.
Chakraborty S, Joseph DV, Bankart MJ, Petersen SA, Wailoo MP. Fetal growth restriction: relation to growth and obesity at the age of 9 years. Arch Dis Child Fetal Neonatal Ed. 2007 Nov;92(6):F479-83. doi: 10.1136/adc.2006.109728. Epub 2007 Feb 14.
Valsamakis G, Kanaka-Gantenbein C, Malamitsi-Puchner A, Mastorakos G. Causes of intrauterine growth restriction and the postnatal development of the metabolic syndrome. Ann N Y Acad Sci. 2006 Dec;1092:138-47. doi: 10.1196/annals.1365.012.
Adams KM, Eschenbach DA. The genetic contribution towards preterm delivery. Semin Fetal Neonatal Med. 2004 Dec;9(6):445-52. doi: 10.1016/j.siny.2004.04.001.
Kramer MS. Intrauterine growth and gestational duration determinants. Pediatrics. 1987 Oct;80(4):502-11.
Hao K, Wang X, Niu T, Xu X, Li A, Chang W, Wang L, Li G, Laird N, Xu X. A candidate gene association study on preterm delivery: application of high-throughput genotyping technology and advanced statistical methods. Hum Mol Genet. 2004 Apr 1;13(7):683-91. doi: 10.1093/hmg/ddh091. Epub 2004 Feb 19.
Clausson B, Lichtenstein P, Cnattingius S. Genetic influence on birthweight and gestational length determined by studies in offspring of twins. BJOG. 2000 Mar;107(3):375-81. doi: 10.1111/j.1471-0528.2000.tb13234.x.
Treloar SA, Macones GA, Mitchell LE, Martin NG. Genetic influences on premature parturition in an Australian twin sample. Twin Res. 2000 Jun;3(2):80-2. doi: 10.1375/136905200320565526.
Other Identifiers
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CHW 09/102, GC 900
Identifier Type: -
Identifier Source: org_study_id
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