ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.


Condition or disease Intervention/treatment
Low Birth Weight Small for Gestational Age Immunodeficiency Other: Cord blood collection for analysis

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Normal Birth Weight (NBW)
Term, healthy infants born at normal birth weights
 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)
 Other: Cord blood collection for analysis
Cord blood will be collected from the placentas at delivery for analysis


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Characterize and compare the Low Birth Weight(LBW) B lymphocyte subtype B1b with that of Normal Birth Weight(NBW) infants. [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Characterize CD19 and CD5 epigenetic regulation in LBW infants as compared to NBW infants. [ Time Frame: 2 years ]

Biospecimen Retention:   Samples With DNA
Blood will be stored as frozen mRNA isolates if parents consent to tissue banking.

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 2 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Term or near-term infants born at less than or equal to 10% normal birth weight for gestation.
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84108
Sponsors and Collaborators
University of Utah
Department of Health and Human Services
Investigators
Principal Investigator: Christian C Yost, M.D. University of Utah
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Christian Con Yost, University of Utah
ClinicalTrials.gov Identifier: NCT00925925     History of Changes
Other Study ID Numbers: 35580
First Posted: June 22, 2009    Key Record Dates
Last Update Posted: May 12, 2015
Last Verified: June 2012

Keywords provided by University of Utah:
Low birth weight
small for gestational age
B-cell function
epigenetics
 B1a
B1b
CD19
CD5

Additional relevant MeSH terms:
Body Weight
Immunologic Deficiency Syndromes
Birth Weight
Signs and Symptoms
Immune System Diseases