Ignite Creation Date:
2024-05-05 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00371241
Status:
COMPLETED
Last Update Posted:
2020-11-05
First Post:
2006-08-30
Brief Title:
Antibody Secreting Cell and Cyotokine Profiles in Neonates on ECMO
Sponsor:
The University of Texas Health Science Center Houston
Organization:
The University of Texas Health Science Center Houston
Study Overview
Official Title:
Antibody Secreting Cell ASC and Immunoactive Protein Profiles in Neonates on Extracorporeal Membrane Oxygenation ECMO
Status:
COMPLETED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Description:
Specific Aims Primary Objective
1 Determine the rise peak and fall of immunoglobulin isotype-specific ASCs 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 cytokinechemokine patterns due to possible underlying infection and exposure to many foreign antigens blood products ECMO circuit A significant portion of these will have ASCs 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 volumesample will be 05-08ml Specimens will be processed using methods well established in our laboratory Briefly PBMCs 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
1 Determine the rise peak and fall of immunoglobulin isotype-specific ASCs 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 cytokinechemokine patterns due to possible underlying infection and exposure to many foreign antigens blood products ECMO circuit A significant portion of these will have ASCs 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 volumesample will be 05-08ml Specimens will be processed using methods well established in our laboratory Briefly PBMCs 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None