Inflammatory Cytokine Quantification in Infants

Overview

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).

Full Title of Study: “Inflammatory Cytokine Quantification in Infants With Documented Sepsis, Congenital Diaphragmatic Hernia and/or ECMO Therapy”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: May 2013

Detailed Description

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.

Arms, Groups and Cohorts

  • Infants with CHD
    • Infants with Congenital Diaphragmatic Hernia (CHD)
  • Infants with sepsis
    • Infants who are culture positive for sepsis and require vasopressor support
  • Infants treated with ECMO
    • Infants suffering cardiopulmonary failure significant enough to require heart/lung bypass treatment with extracorporeal membrane oxygenation (ECMO)

Clinical Trial Outcome Measures

Primary Measures

  • 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).

Secondary Measures

  • 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).

Participating in This Clinical Trial

Inclusion Criteria

  • Gestational age ≥ 34 weeks, – Indwelling vascular catheter available for blood draws, – Documented culture positive sepsis on vasopressors , and/or – Congenital diaphragmatic hernia (CDH), and/or – ECMO therapy Exclusion Criteria:

  • Other major congenital anomalies – Lack of parental consent

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 2 Months

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Utah
  • Provider of Information About this Clinical Study
    • Dr. Donald Null, University of Utah
  • Overall Official(s)
    • Donald Null, MD, Principal Investigator, University of Utah

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