Inflammatory Cytokine Quantification in Infants With Documented Sepsis, Congenital Diaphragmatic Hernia and/or ECMO Therapy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Sepsis
- Sponsor
- University of Utah
- Enrollment
- 21
- Locations
- 2
- Primary Endpoint
- TNF-alpha, Baseline
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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 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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
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 Outcomes
- TNF-alpha, Maximum(up to 2 weeks)