Antibody Secreting Cell and Cyotokine Profiles in Neonates on ECMO

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.

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Key information

Conditions

Persistent Fetal Circulation Syndrome Congenital, Hereditary, and Neonatal Diseases and Abnormalities Diaphragmatic Hernia Female Urogenital Diseases and Pregnancy Complications Fetal Diseases Hernia Hernia, Diaphragmatic Hypertension, Pulmonary Infant, Newborn, Diseases Infections Inflammation Internal Hernia Lung Diseases Lung Injury Meconium Aspiration Meconium Aspiration Syndrome Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pregnancy Complications Respiration Disorders Respiratory Tract Diseases Sepsis Systemic Inflammatory Response Syndrome Urogenital Diseases

Age range

1 day–30 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Hermann Hospital

Houston, Texas, 77030, United States

About this study

Specific Aims Primary Objective

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

Memorial Hermann Hospital

Registry information

Official study title

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

Important dates

Study start: 2006
Study completion: 2007
First posted: Sep 4, 2006
Registry last updated: Nov 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed