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 |
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).
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.
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
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