An observational study in Sepsis, Congenital Diaphragmatic Hernia and Neonatal Cardiopulmonary Failure, sponsored by University of Utah. Completed at 2 sites in United States. Open to participants aged Up to 2 Months. Per ClinicalTrials.gov, last updated 2015-05-04.
Sponsored by University of Utah · Observational
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.
1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.
This study's enrollment of 21 is below the median of 160 across 931 observational studies indexed under Sepsis.
Browse Sepsis studies →University of Utah is the lead sponsor of 969 studies on the registry; 178 are open to participants now.
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Infants admitted into the NICU at the University of Utah Health Sciences Centers and Primary Children's Medical Center.
Exclusion Criteria:
Infants with Congenital Diaphragmatic Hernia (CHD)
Infants who are culture positive for sepsis and require vasopressor support
Infants suffering cardiopulmonary failure significant enough to require heart/lung bypass treatment with extracorporeal membrane oxygenation (ECMO)
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).
Time frame: Baseline
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).
Time frame: up to 2 weeks
| Milestone | Infants With CHD | Infants With Sepsis | Infants Treated With ECMO |
|---|---|---|---|
| Started | 0 | 0 | 21 |
| Completed | 0 | 0 | 21 |
| Not completed | 0 | 0 | 0 |
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).
| pg/mL | Infants With CHD | Infants With Sepsis | Infants Treated With ECMO |
|---|---|---|---|
| TNF-alpha, Baseline | — | — | 8.88 ± 4.58 |
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).
| pg/mL | Infants With CHD | Infants With Sepsis | Infants Treated With ECMO |
|---|---|---|---|
| TNF-alpha, Maximum | — | — | 33.1 ± 9.373 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Infants With CHD | — | — | — |
| Infants With Sepsis | — | — | — |
| Infants Treated With ECMO | — | 0/21 (0%) | 0/21 (0%) |
| Age, Categorical(participants) | Infants With CHD | Infants With Sepsis | Infants Treated With ECMO | Total |
|---|---|---|---|---|
| <=18 years | — | — | 21 | 21 |
| Between 18 and 65 years | — | — | 0 | 0 |
| >=65 years | — | — | 0 | 0 |
| Age, Continuous(Days) | Infants With CHD | Infants With Sepsis | Infants Treated With ECMO | Total |
|---|---|---|---|---|
| Mean | — | — | 1 ± 1 | 1 ± 1 |
| Gender(participants) | Infants With CHD | Infants With Sepsis | Infants Treated With ECMO | Total |
|---|---|---|---|---|
| Female | — | — | 8 | 8 |
| Male | — | — | 13 | 13 |
| Region of Enrollment(participants) | Infants With CHD | Infants With Sepsis | Infants Treated With ECMO | Total |
|---|---|---|---|---|
| United States | — | — | 21 | 21 |
This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.
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University of Utah