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Epigenetic Markers of B-Cell Function in Low Birth Weight Infants

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ClinicalTrials.gov Identifier: NCT00925925
Recruitment Status : Completed
First Posted : June 22, 2009
Last Update Posted : May 12, 2015
Sponsor:
Collaborator:
Department of Health and Human Services
Information provided by:
University of Utah

June 18, 2009
June 22, 2009
May 12, 2015
June 2009
May 2012   (Final data collection date for primary outcome measure)
Characterize and compare the Low Birth Weight(LBW) B lymphocyte subtype B1b with that of Normal Birth Weight(NBW) infants. [ Time Frame: 2 years ]
Same as current
Complete list of historical versions of study NCT00925925 on ClinicalTrials.gov Archive Site
Characterize CD19 and CD5 epigenetic regulation in LBW infants as compared to NBW infants. [ Time Frame: 2 years ]
Same as current
Not Provided
Not Provided
 
Epigenetic Markers of B-Cell Function in Low Birth Weight Infants
Epigenetic Markers of B-Cell Function in Low Birth Weight Infants

Low birth weight (LBW) status (< 10% for gestational age at birth) is associated with increased risk for diseases such as type II diabetes mellitus, hypertension, chronic obstructive pulmonary disease and coronary artery disease in adults, and represents one example of the "fetal onset of adult disease" hypothesis. Recent data strongly associates LBW status with impaired innate and adaptive immunity leading to increased risk for severe infections during adolescence or early adulthood. Animal studies suggest that the ratio of certain B lymphocyte subpopulations, the B1a and B1b cells, determines whether deficits in immunity occur.

This study will determine the ratio of B1b to B1a lymphocyte subpopulations in the cord blood of infants born LBW in the late preterm to term gestations (> 34 weeks at birth) and compare those ratios with those of normal birth weight (NBW) controls in a nested case control study design.

Furthermore, animal studies suggest that the expression patterns of CD5 and CD19 proteins determines the cellular phenotype of the B lymphocyte, that of a B1a or a B1b cell, and that the regulatory regions controlling their expression are epigenetically vulnerable. The investigators will therefore isolate DNA and RNA from both B lymphocyte subpopulations and determine whether epigenetic changes to the regulatory regions of the genes coding for CD5 and CD19 protein expression occur in LBW lymphocyte subpopulations as compared to the lymphocytes from NBW infants.

This proposal will be the first human study to examine epigenetic determination of a maladaptive phenotype following LBW status at birth in a specific cell type leading to a specific impairment of innate and adaptive immunity.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
Blood will be stored as frozen mRNA isolates if parents consent to tissue banking.
Non-Probability Sample
Term or near-term infants born at less than or equal to 10% normal birth weight for gestation.
  • Low Birth Weight
  • Small for Gestational Age
  • Immunodeficiency
Other: Cord blood collection for analysis
Cord blood will be collected from the placentas at delivery for analysis
  • Normal Birth Weight (NBW)
    Term, healthy infants born at normal birth weights
    Intervention: Other: Cord blood collection for analysis
  • Low Birth Weight (LBW)
    Infants born at > or equal to 34 0/7 weeks with a birth weight at < or equal to 10% for gestational age at birth (Small for Gestational Age, SGA)
    Intervention: Other: Cord blood collection for analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
160
May 2012
May 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Infants delivered at University of Utah Health Sciences Center
  • For LBW group:

    • Gestational age > or = to 34 0/7 weeks
    • Birth weight < or = to 10% for gestational age
  • For NBW group:

    • Term infant controls delivered without complication
  • Adequate cord blood sample obtained directly after birth
  • Parents or guardians must have signed informed consent

Exclusion Criteria:

  • Infants with major congenital anomalies will be excluded
Sexes Eligible for Study: All
up to 2 Hours   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00925925
35580
No
Not Provided
Not Provided
Christian Con Yost, University of Utah
University of Utah
Department of Health and Human Services
Principal Investigator: Christian C Yost, M.D. University of Utah
University of Utah
June 2012