Congenital Diaphragmatic Hernia, Neonatal Cardiopulmonary Failure, Sepsis
Conditions
Keywords
inflammatory cytokines, extracorporeal membrane oxygenation, ECMO
Brief summary
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
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.
Interventions
None listed
Sponsors
University of Utah
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 2 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| TNF-alpha, Baseline | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| TNF-alpha, Maximum | up to 2 weeks | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Infants With CHD Infants with Congenital Diaphragmatic Hernia (CHD) | 0 |
| Infants With Sepsis Infants who are culture positive for sepsis and require vasopressor support | 0 |
| Infants Treated With ECMO Infants suffering cardiopulmonary failure significant enough to require heart/lung bypass treatment with extracorporeal membrane oxygenation (ECMO) | 21 |
| Total | 21 |
Baseline characteristics
| Characteristic | Total | Infants Treated With ECMO |
|---|---|---|
| Age, Categorical <=18 years | 21 participants | 21 participants |
| Age, Categorical >=65 years | 0 participants | 0 participants |
| Age, Categorical Between 18 and 65 years | 0 participants | 0 participants |
| Age, Continuous | 1 Days STANDARD_DEVIATION 1 | 1 Days STANDARD_DEVIATION 1 |
| Gender Female | 8 participants | 8 participants |
| Gender Male | 13 participants | 13 participants |
| Region of Enrollment United States | 21 participants | 21 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 21 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 21 |
Outcome results
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).
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Infants Treated With ECMO | TNF-alpha, Baseline | 8.88 pg/mL | Standard Error 4.58 |
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).
Time frame: up to 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Infants Treated With ECMO | TNF-alpha, Maximum | 33.1 pg/mL | Standard Error 9.373 |