Inflammatory Cytokine Quantification in Infants

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Congenital Diaphragmatic Hernia, Sepsis, Neonatal Cardiopulmonary Failure

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 2 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Infants with CHD<br>Infants with Congenital Diaphragmatic Hernia (CHD) | |
| Infants with sepsis<br>Infants who are culture positive for sepsis and require vasopressor support | |
| Infants treated with ECMO<br>Infants suffering cardiopulmonary failure significant enough to require heart/lung bypass treatment with extracorporeal membrane oxygenation (ECMO) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TNF-alpha, 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). | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TNF-alpha, Maximum | 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). | up to 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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inflammatory cytokines, extracorporeal membrane oxygenation, ECMO