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

Low Birth Weight Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00925925
• Other study ID #: 35580
• Status: Completed
• Phase: N/A
• First received: June 18, 2009
• Last updated: May 11, 2015
• Start date: June 2009
• Est. completion date: May 2012

Study information

• Verified date: June 2012
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 2 Hours

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Birth Weight
• Body Weight
• Immunodeficiency
• Immunologic Deficiency Syndromes
• Low Birth Weight
• Small for Gestational Age

Intervention

Other:
• Cord blood collection for analysis
Cord blood will be collected from the placentas at delivery for analysis

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	Department of Health and Human Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characterize and compare the Low Birth Weight(LBW) B lymphocyte subtype B1b with that of Normal Birth Weight(NBW) infants.		2 years	No
Secondary	Characterize CD19 and CD5 epigenetic regulation in LBW infants as compared to NBW infants.		2 years	No