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
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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.
Condition or disease | Intervention/treatment |
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Low Birth Weight Small for Gestational Age Immunodeficiency | Other: Cord blood collection for analysis |
Study Type : | Observational |
Actual Enrollment : | 64 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
Official Title: | Epigenetic Markers of B-Cell Function in Low Birth Weight Infants |
Study Start Date : | June 2009 |
Actual Primary Completion Date : | May 2012 |
Actual Study Completion Date : | May 2012 |

Group/Cohort | Intervention/treatment |
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Normal Birth Weight (NBW)
Term, healthy infants born at normal birth weights
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Other: Cord blood collection for analysis
Cord blood will be collected from the placentas at delivery 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)
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Other: Cord blood collection for analysis
Cord blood will be collected from the placentas at delivery for analysis |
- Characterize and compare the Low Birth Weight(LBW) B lymphocyte subtype B1b with that of Normal Birth Weight(NBW) infants. [ Time Frame: 2 years ]
- Characterize CD19 and CD5 epigenetic regulation in LBW infants as compared to NBW infants. [ Time Frame: 2 years ]
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | up to 2 Hours (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Infants delivered at University of Utah Health Sciences Center
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For LBW group:
- Gestational age > or = to 34 0/7 weeks
- Birth weight < or = to 10% for gestational age
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00925925
United States, Utah | |
University of Utah | |
Salt Lake City, Utah, United States, 84108 |
Principal Investigator: | Christian C Yost, M.D. | University of Utah |
Responsible Party: | Christian Con Yost, University of Utah |
ClinicalTrials.gov Identifier: | NCT00925925 |
Other Study ID Numbers: |
35580 |
First Posted: | June 22, 2009 Key Record Dates |
Last Update Posted: | May 12, 2015 |
Last Verified: | June 2012 |
Low birth weight small for gestational age B-cell function epigenetics |
B1a B1b CD19 CD5 |
Body Weight Birth Weight |