Clinical Trial: Antibody Secreting Cell and Cyotokine Profiles in Neonates on ECMO

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Antibody Secreting Cell (ASC) and Immunoactive Protein Profiles in Neonates on Extracorporeal Membrane Oxygenation (ECMO)

Brief Summary: Infants are placed on ECMO for correction of reversible respiratory failure. Often, because a few of the reasons for respiratory failure show us similar things in the baby, it is difficult to determine exactly which is causing the biggest problem. We are now capable of measuring certain cells and proteins in these infants that may help us more accurately diagnose the exact problem. We hypothesize that infants placed on ECMO will show unique antibody-secreting cells responses and patterns of cytokine and chemokine (protein) response to illness and to the ECMO circuit. If we find unique patterns to these cells or proteins, they may be able to predict outcomes or guide treatment of these infants.

Detailed Summary:

Specific Aims Primary Objective

1. Determine the rise, peak, and fall of immunoglobulin isotype-specific ASC's, and immunoactive proteins (cytokines and chemokines) from sequential samples of peripheral blood from infants on ECMO.

Secondary Objectives:

  1. Determine the most appropriate time to sample blood from infants with suspected sepsis for ASC diagnostic assay.
  2. Characterize the incidence of culture-negative sepsis that leads to ECMO.
  3. Determine immunoglobulin isotype-specific levels of ASC in infants with and without infection.
  4. Establish an archive of mononuclear cells and plasma to use in development of pathogen specific ASC assays.

Hypothesis Infants on ECMO will have a high ASC response and unique cytokine/chemokine patterns due to possible underlying infection and exposure to many foreign antigens (blood products, ECMO circuit). A significant portion of these will have ASC's with specificity for common causes of neonatal sepsis that is not detected by routine blood culture.

Procedures:

Residual samples will be collected from those used in routine procedures for infants on ECMO. The approximate volume/sample will be 0.5-0.8ml. Specimens will be processed using methods well established in our laboratory. Briefly, PBMC's will be isolated via Ficoll gradient and archived in liquid nitrogen at -80C. Batch analysis of ASC levels and lymphocyte proliferation activity will be performed when sufficient number of specimens are accumulated. A detailed profile and quantification of immune cel
Sponsor: The University of Texas Health Science Center, Houston

Current Primary Outcome:

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: The University of Texas Health Science Center, Houston

Dates:
Date Received: August 30, 2006
Date Started: September 2006
Date Completion:
Last Updated: December 3, 2007
Last Verified: December 2007