Clinical Trials Directory

Trials / Completed

CompletedNCT00925925

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

Status
Completed
Phase
Study type
Observational
Enrollment
64 (actual)
Sponsor
University of Utah · Academic / Other
Sex
All
Age
2 Hours
Healthy volunteers
Accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
OTHERCord blood collection for analysisCord blood will be collected from the placentas at delivery for analysis

Timeline

Start date
2009-06-01
Primary completion
2012-05-01
Completion
2012-05-01
First posted
2009-06-22
Last updated
2015-05-12

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00925925. Inclusion in this directory is not an endorsement.