Clinical Trial: Inflammatory Cytokine Quantification in Infants

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

Official Title: Inflammatory Cytokine Quantification in Infants With Documented Sepsis, Congenital Diaphragmatic Hernia and/or ECMO Therapy

Brief Summary: This study proposes to quantify inflammatory cytokine profiles in three neonatal disease states, namely, neonatal sepsis, infants with a congenital diaphragmatic hernia defect, and infants suffering cardiopulmonary failure significant enough to require heart/lung bypass treatment with extracorporeal membrane oxygenation (ECMO).

Detailed Summary: Very small blood samples (500 microliters) will be collected serially in these patients and analyzed with current cytokine array technology. A convenience sample of 60 patients, 20 with each of these diagnoses, will be collected over a 2 year period. These data will provide baseline information for possible therapeutic intervention with agents that enhance or suppress specific mediators, or adjust mediator balance to promote patient healing.
Sponsor: University of Utah

Current Primary Outcome: TNF-alpha, Baseline [ Time Frame: Baseline ]

This study will quantify inflammatory cytokine profiles in three neonatal disease states, namely, neonatal sepsis with cardiovascular instability, infants with a congenital diaphragmatic hernia defect, and infants suffering cardiopulmonary failure significant enough to require heart/lung bypass treatment with extracorporeal membrane oxygenation (ECMO).


Original Primary Outcome: Quantification of inflammatory cytokine profiles in three neonatal diseases. [ Time Frame: up to 2 weeks ]

This study will quantify inflammatory cytokine profiles in three neonatal disease states, namely, neonatal sepsis with cardiovascular instability, infants with a congenital diaphragmatic hernia defect, and infants suffering cardiopulmonary failure significant enough to require heart/lung bypass treatment with extracorporeal membrane oxygenation (ECMO).


Current Secondary Outcome: TNF-alpha, Maximum [ Time Frame: up to 2 weeks ]

This study will quantify inflammatory cytokine profiles in three neonatal disease states, namely, neonatal sepsis with cardiovascular instability, infants with a congenital diaphragmatic hernia defect, and infants suffering cardiopulmonary failure significant enough to require heart/lung bypass treatment with extracorporeal membrane oxygenation (ECMO).


Original Secondary Outcome:

Information By: University of Utah

Dates:
Date Received: June 22, 2010
Date Started: June 2010
Date Completion:
Last Updated: May 1, 2015
Last Verified: December 2014