Antibody Secreting Cell and Cyotokine Profiles in Neonates on ECMO
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Purpose
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.
| Condition |
|---|
|
Persistent Fetal Circulation Syndrome Diaphragmatic Hernia Meconium Aspiration Sepsis |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Antibody Secreting Cell (ASC) and Immunoactive Protein Profiles in Neonates on Extracorporeal Membrane Oxygenation (ECMO) |
Plasma and whole blood
| Enrollment: | 12 |
| Study Start Date: | September 2006 |
| Study Completion Date: | November 2007 |
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:
- Determine the most appropriate time to sample blood from infants with suspected sepsis for ASC diagnostic assay.
- Characterize the incidence of culture-negative sepsis that leads to ECMO.
- Determine immunoglobulin isotype-specific levels of ASC in infants with and without infection.
- 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 cells will be determined by Fluorescent Activated Cell Sorter (FACS) staining for CD3, CD4, CD8, CD27, CD38, CD45, and HLA-DR. A bead micro-array will be used to detect levels of immunoactive molecules, also done on the FACS. The proteins detected will include, but may not be limited to, the following: IL1β, IL2, IL4, IL5, IL6, IL7, IL8, IL10, IL12p70, IL13, IL17, GCSF, GMCSF, IFN-γ, MCP-1, MIP-1β, TNFα. The ASC procedure be that established by Van de Verg modified to use membrane surface microculture plates in place of agar with outcomes read by CTL analyzer in place of manual count. LPA assays will use long established techniques.
Eligibility| Ages Eligible for Study: | up to 30 Days |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Infants requiring ECMO
Inclusion Criteria:
- 1) term newborn infants >24 hours and ≤ 30 days old 2) Placed on ECMO in the NICU at MHCH 3) Parental consent obtained within 48 hours of being placed on ECMO
Exclusion Criteria:
- 1) Infant > 30 days old 2) Infant NOT on ECMO 3) Withdrawal of parental consent
Contacts and Locations| United States, Texas | |
| Memorial Hermann Hospital | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | James M Murpy, PhD | University of Texas Health Science Center at Houston- Division of Infectious Diseases |
More Information
Publications:
| Responsible Party: | James R. Murphy, The University of Texas Health Science Center, HoustonU |
| ClinicalTrials.gov Identifier: | NCT00371241 History of Changes |
| Other Study ID Numbers: | HSC-MS-06-0122 |
| Study First Received: | August 30, 2006 |
| Last Updated: | December 3, 2007 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by The University of Texas Health Science Center, Houston:
|
ECMO extracorporeal membrane oxygenation cytokines chemokines |
Additional relevant MeSH terms:
|
Hernia Hernia, Diaphragmatic Hernia, Hiatal Meconium Aspiration Syndrome Persistent Fetal Circulation Syndrome Sepsis Pathological Conditions, Anatomical Lung Injury Lung Diseases Respiratory Tract Diseases Respiration Disorders Fetal Diseases |
Pregnancy Complications Infant, Newborn, Diseases Hypertension, Pulmonary Infection Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes Antibodies Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013