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More info
You can access this
clinical trial
if you have
Low Birth Weight, Small for Gestational Age or Immunodeficiency
and you are
under 2
years old
-
This is an observational trial.
You are contributing to medical knowledge about your condition.
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The purpose

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.

Provided treatments

  • Other: Cord blood collection for analysis
Tris trial is registered with FDA with number: NCT00925925. The sponsor of the trial is University of Utah and it is looking for 64 volunteers for the current phase.
Official trial title:
Epigenetic Markers of B-Cell Function in Low Birth Weight Infants