NCT01439048

Brief Summary

The purpose of this study is to determine if changes in specific gene products in the placenta or cord/infant blood affect a baby's 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

September 21, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 22, 2011

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

August 28, 2015

Status Verified

August 1, 2015

Enrollment Period

6.2 years

First QC Date

September 21, 2011

Last Update Submit

August 27, 2015

Conditions

Premature Birth

Keywords

PlacentaCord BloodPAHEnvironmental MarkersToll-Like Receptors

Outcome Measures

Primary Outcomes (1)

  • Comparisons of placental gene expression and cord blood immune markers

    Placental gene expression and cord-blood immune markers/function will be compared between 50 term infants and 150 preterm infants. Further, among preterm infants it will be determined whether certain patterns of gene expression and immune marker distribution are associated with specific diseases/condition and growth outcomes. Similarly, epigenetic changes in the immune genes and markers of environmental exposure will be compared between preterm infants and term infants. Associations between environment exposures and epigenetic changes and diseases of prematurity will also be determined.

    through hospital discharge

Study Arms (2)

Term infants

Infants born at greater than 37 weeks gestation

Preterm Infants

Infants born at less than 37 weeks gestation

Eligibility Criteria

Age1 Minute - 3 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Infants who are born both premature (less than 37 weeks gestation) and full term infants (greater than 37 weeks gestation).

You may qualify if:

  • all infants born alive

You may not qualify if:

  • infants who are born with no signs of life

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Froedtert Memorial Lutheran Hospital

Wauwatosa, Wisconsin, 53226, United States

Location

Related Publications (12)

  • 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.

    PMID: 9374556BACKGROUND

  • 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.

    PMID: 16711376BACKGROUND

  • 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.

    PMID: 14510320BACKGROUND

  • 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.

    PMID: 12165580BACKGROUND

  • 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.

    PMID: 15547163BACKGROUND

  • 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.

    PMID: 17301112BACKGROUND

  • 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.

    PMID: 17308140BACKGROUND

  • 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.

    PMID: 15691782BACKGROUND

  • Kramer MS. Intrauterine growth and gestational duration determinants. Pediatrics. 1987 Oct;80(4):502-11.

    PMID: 3658568BACKGROUND

  • 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.

    PMID: 14976157BACKGROUND

  • 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.

    PMID: 10740335BACKGROUND

  • 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.

    PMID: 10918619BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, placenta

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Venkatesh Sampath, MBBS

    Medical College of Wisconsin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Physician

Study Record Dates

First Submitted

September 21, 2011

First Posted

September 22, 2011

Study Start

June 1, 2009

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

August 28, 2015

Record last verified: 2015-08

Locations

US(1)