Inflammatory Cytokine Quantification in Infants



Status:Completed
Conditions:Hospital, Gastrointestinal
Therapuetic Areas:Gastroenterology, Other
Healthy:No
Age Range:Any
Updated:4/13/2015
Start Date:June 2010
End Date:June 2014

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

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).

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.

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
We found this trial at
2
sites
100 N Mario Capecchi Dr
Salt Lake City, Utah 84132
(801) 662-1000
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
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