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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Infants admitted into the NICU at the University of Utah Health Sciences Centers and Primary Children's Medical Center.
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| Name | Affiliation | Role |
|---|---|---|
| Donald Null, MD | University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Utah | Salt Lake City | Utah | 84108 | United States | ||
| Primary Children's Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Infants With CHD | Infants with Congenital Diaphragmatic Hernia (CHD) |
| FG001 | Infants With Sepsis | Infants who are culture positive for sepsis and require vasopressor support |
| FG002 | Infants Treated With ECMO | Infants suffering cardiopulmonary failure significant enough to require heart/lung bypass treatment with extracorporeal membrane oxygenation (ECMO) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Infants With CHD | Infants with Congenital Diaphragmatic Hernia (CHD) |
| BG001 | Infants With Sepsis | Infants who are culture positive for sepsis and require vasopressor support |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Mean | Standard Error | pg/mL | Baseline |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Infants With CHD | Infants with Congenital Diaphragmatic Hernia (CHD) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Christian Yost | University of Utah | 801/581-7052 | christian.yost@hmbg.utah.edu |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| D065630 | Hernias, Diaphragmatic, Congenital |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| Salt Lake City |
| Utah |
| 84112 |
| United States |
| BG002 | Infants Treated With ECMO | Infants suffering cardiopulmonary failure significant enough to require heart/lung bypass treatment with extracorporeal membrane oxygenation (ECMO) |
| BG003 | Total | Total of all reporting groups |
| participants |
|
| Age, Continuous | Mean | Standard Deviation | Days |
|
| Gender | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 |
| Infants Treated With ECMO |
Infants suffering cardiopulmonary failure significant enough to require heart/lung bypass treatment with extracorporeal membrane oxygenation (ECMO) |
|
|
| Secondary | 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). | Posted | Mean | Standard Error | pg/mL | up to 2 weeks |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Infants With Sepsis | Infants who are culture positive for sepsis and require vasopressor support | 0 | 0 | 0 | 0 |
| EG002 | Infants Treated With ECMO | Infants suffering cardiopulmonary failure significant enough to require heart/lung bypass treatment with extracorporeal membrane oxygenation (ECMO) | 0 | 21 | 0 | 21 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006548 | Hernia, Diaphragmatic |
| D000082122 | Internal Hernia |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |